section_id,title_number,title_name,chapter,subchapter,part_number,part_name,subpart,subpart_name,section_number,section_heading,agency,authority,source_citation,amendment_citations,full_text
14:14:3.0.1.1.2.1.1.1,14,Aeronautics and Space,I,G,111,PART 111—PILOT RECORDS DATABASE,A,Subpart A—General,,§ 111.1 Applicability.,FAA,,,"[Docket FAA-2020-0246, Amdt. 111-1, 86 FR 31060, June 10, 2021, as amended by Docket FAA-2023-1275, Amdt. 111-2, 89 FR 92486, Nov. 21, 2024]","(a) This part prescribes rules governing the use of the Pilot Records Database (PRD).

(b) Except as provided in subsection (c) of this section, this part applies to:

(1) Each operator that holds an air carrier or operating certificate issued in accordance with part 119 of this chapter and is authorized to conduct operations under part 121, 125, or 135 of this chapter.

(2) Each operator that holds management specifications for a fractional ownership program issued in accordance with subpart K of part 91 of this chapter.

(3) Each operator that holds a letter of authorization issued in accordance with § 91.147 of this chapter.

(4) Each operator that operates two or more aircraft described in paragraph (b)(4)(i), (ii), or (iii) of this section, in furtherance of or incidental to a business, solely pursuant to the general operating and flight rules in part 91 of this chapter, or that operates aircraft pursuant to a Letter of Deviation Authority issued under § 125.3 of this chapter.

(i) Standard airworthiness airplanes that require a type rating under § 61.31(a) of this chapter.

(ii) Turbine-powered rotorcraft.

(iii) Large powered-lift.

(5) Each entity that conducts public aircraft operations as defined in 49 U.S.C. 40102(a)(41) on a flight that meets the qualification criteria for public aircraft status in 49 U.S.C. 40125, unless the entity is any branch of the United States Armed Forces, National Guard, or reserve component of the Armed Forces.

(6) Each trustee in bankruptcy of any operator or entity described in this paragraph, subject to the following criteria:

(i) If any operator subject to the requirements of this subpart files a petition for protection under the Federal bankruptcy laws, the trustee appointed by the bankruptcy court must comply with the requirements of subparts A and C of this part.

(ii) The operator may delegate its authority to the trustee appointed by the bankruptcy court to access the PRD on its behalf in accordance with § 111.20 or the trustee may submit an application to the FAA requesting access to the PRD consistent with the requirements of § 111.15.

(7) Each person that submits or is identified on the application described in § 111.15 and is approved by the Administrator to access the PRD.

(8) Each person who is employed as a pilot by, or is seeking employment as a pilot with, an operator subject to the applicability of this part.

(c) This part does not apply to foreign air carriers or operators subject to part 375 of this title."
14:14:3.0.1.1.2.1.1.2,14,Aeronautics and Space,I,G,111,PART 111—PILOT RECORDS DATABASE,A,Subpart A—General,,§ 111.5 Compliance date.,FAA,,,,"(a) Compliance with this part is required by September 9, 2024, except as provided in §§ 111.15, 111.100, 111.200, and 111.255.

(b) Beginning on September 9, 2024, the Pilot Records Improvement Act (PRIA) ceases to be effective and will not be an available alternative to PRD for operators, entities, or trustees to which this subpart applies."
14:14:3.0.1.1.2.1.1.3,14,Aeronautics and Space,I,G,111,PART 111—PILOT RECORDS DATABASE,A,Subpart A—General,,§ 111.10 Definitions.,FAA,,,,"For purposes of this part, the term—

Authorized user  means an individual who is employed by an operator, entity, or trustee and who is designated by a responsible person to access the PRD on behalf of the employer for purposes of reporting and evaluating records that pertain to an individual pilot applicant.

Begin service as a pilot  means the earliest date on which a pilot serves as a pilot flight crewmember or is assigned duties as a pilot in flight for an operator or entity that is subject to the applicability of this part.

Final disciplinary action record  means a last-in-time record of corrective or punitive action taken by an operator or entity who is subject to the applicability of this part in response to an event pertaining to pilot performance. No disciplinary action is considered final until the operator determines the action is not subject to any pending dispute.

Final separation from employment record  means a last-in-time record of any action ending the employment relationship between a pilot and an operator or entity who is subject to the applicability of this part. No separation from employment is considered final until the operator determines the separation is not subject to any pending dispute.

Historical record  means a record that an operator subject to the applicability of Subpart C of this part must generate and maintain in accordance with 49 U.S.C. 44703(h)(4) and must report to the PRD in accordance with 49 U.S.C. 44703(i)(15)(C)(iii).

PRD Date of Hire  means:

(1) The earliest date on which an individual:

(i) Begins any form of required training in preparation for the individual's service as a pilot on behalf of an operator or entity subject to the applicability of this part; or

(ii) Performs any duty as a pilot for an operator or entity subject to the applicability of this part.

(2) This definition includes both direct employment and employment that occurs on a contract basis for any form of compensation.

Proxy  means a person who is designated by a responsible person to access the PRD on behalf of an operator, entity, or trustee subject to the applicability of this part for purposes of reporting or retrieving records.

Record pertaining to pilot performance  means a record of an activity or event directly related to a pilot's responsibilities or completion of the core duties in conducting safe aircraft operations, as assigned by the operator employing the pilot.

Reporting entity  means an operator, entity, or trustee that is subject to the applicability of subpart C of part 111, including its responsible person, authorized users, and proxies.

Responsible person  means the individual identified on the application required by § 111.15 and who meets at least one of the criteria in § 111.15(e).

Reviewing entity  means operator that is subject to the applicability of subpart B of part 111, including its responsible person, authorized users, and proxies."
14:14:3.0.1.1.2.1.1.4,14,Aeronautics and Space,I,G,111,PART 111—PILOT RECORDS DATABASE,A,Subpart A—General,,§ 111.15 Application for database access.,FAA,,,"[86 FR 31060, June 10, 2021, as amended at 86 FR 31067, June 10, 2021]","(a)(1) Each operator or entity to which this part applies that plans to initiate operations after September 8, 2021, must submit the application required by this section to the FAA at least 30 days before the operator or entity initiates aircraft operations.

(2) Within 30 days of appointment by a bankruptcy court as described in § 111.1(b)(6)(i), a trustee must submit the application required by this section or receive delegation of access from the applicable operator or entity.

(b) The application required by this section must contain the following information:

(1) The full name, job title, telephone number, and electronic mail address of the responsible person who is authorized to submit the application in accordance with paragraph (d) of this section;

(2) The name of the operator, entity, or trustee;

(3) The FAA air carrier or operating certificate number, as applicable; and

(4) Any other item the Administrator determines is necessary to verify the identity of all individuals designated by an operator, entity, or trustee to access the PRD.

(c) The application required by this section must be submitted by a responsible person who holds at least one of the following positions, unless otherwise approved by the Administrator:

(1) For each operator that holds an air carrier or operating certificate issued in accordance with part 119 for operations under part 121, a person serving in a management position required by § 119.65(a) of this chapter.

(2) For each operator that holds an operating certificate issued in accordance with part 119 for operations under part 125, a person serving in a management position required by § 125.25(a) of this chapter.

(3) For each operator that holds an operating certificate issued in accordance with part 119 for operations under part 135 using more than one pilot in its operations, a person serving in a management position required by § 119.69(a) of this chapter.

(4) For each operator that holds an operating certificate issued in accordance with part 119 for operations under part 135 authorized to use only one pilot in its operations, the pilot named in that certificate holder's operation specifications.

(5) For each operator that holds a letter of authorization issued in accordance with § 91.147 of this chapter, an individual designated as the responsible person on the operator's letter of authorization.

(6) For each operator that holds management specifications for a fractional ownership program issued in accordance with subpart K of part 91 of this chapter, an authorized individual designated by the fractional ownership program manager, as defined in § 91.1001(b) of this chapter, who is employed by the fractional ownership program and whose identity the Administrator has verified.

(7) For any other operator or entity subject to the applicability of this part, or any trustee appointed in a bankruptcy proceeding, an individual authorized to sign and submit the application required by this section who is employed by the operator and whose identity the Administrator has verified.

(d) Each operator, entity, or trustee must submit to the FAA—

(1) An amended application for database access no later than 30 days after any change to the information included on the initial application for database access occurs, except when the change pertains to the identification or designation of the responsible person.

(2) An amended application identifying another responsible person eligible for database access in accordance with this section, immediately when the operator, entity, or trustee is aware of information that would cause the current responsible person's database access to be cancelled or denied.

(e) Upon approval by the FAA of a request for access to the PRD, each person identified in paragraph (e) is authorized to:

(1) Access the database for purposes consistent with the provisions of this part, on behalf of the operator, entity, or trustee for which the person is authorized, for purposes consistent with the provisions of this part; and

(2) Delegate PRD access to authorized users and proxies in accordance with § 111.20."
14:14:3.0.1.1.2.1.1.5,14,Aeronautics and Space,I,G,111,PART 111—PILOT RECORDS DATABASE,A,Subpart A—General,,§ 111.20 Database access.,FAA,,,,"(a)  Delegation.  The responsible person may delegate PRD access to authorized users or proxies for purposes of compliance by the operator, entity, or trustee with the requirements of subpart B or C of this part.

(b)  Terms for access.  No person may use the PRD for any purpose other than to inform a hiring decision concerning a pilot or to report information on behalf of the operator, entity, or trustee.

(c)  Continuing access for authorized users and proxies.  PRD access by authorized users and proxies is contingent on the continued validity of the responsible person's electronic access. If a responsible person's electronic access is cancelled, the database access of authorized users and proxies will be cancelled unless the operator, entity, or trustee submits an amended application for database access and receives FAA approval of that application in accordance with § 111.15."
14:14:3.0.1.1.2.1.1.6,14,Aeronautics and Space,I,G,111,PART 111—PILOT RECORDS DATABASE,A,Subpart A—General,,§ 111.25 Denial of access.,FAA,,,,"(a) The Administrator may deny PRD access to any person for failure to comply with any of the duties or responsibilities prescribed by this part or as necessary to preserve the security and integrity of the database, which includes but is not limited to—

(1) Making a fraudulent or intentionally false report of information to the database; or

(2) Misusing or misappropriating user rights or protected information in the database.

(b) The Administrator may deny any operator or entity access to the PRD if the Administrator revokes or suspends the operating certificate or other authorization to operate.

(c) Any person whose access to the database has been denied by the Administrator may submit a request for reconsideration of the denial in a form and manner the Administrator provides. Database access will not be permitted pending reconsideration."
14:14:3.0.1.1.2.1.1.7,14,Aeronautics and Space,I,G,111,PART 111—PILOT RECORDS DATABASE,A,Subpart A—General,,§ 111.30 Prohibited access and use.,FAA,,,,"(a) No person may access the database for any purpose other than the purposes provided by this part.

(b) No person may share, distribute, publish, or otherwise release any record accessed in the database to any person or individual not directly involved in the hiring decision, unless specifically authorized by law or unless the person sharing or consenting to share the record is the subject of the record.

(c) Each person that accesses the PRD to retrieve a pilot's records must protect the confidentiality of those records and the privacy of the pilot as to those records."
14:14:3.0.1.1.2.1.1.8,14,Aeronautics and Space,I,G,111,PART 111—PILOT RECORDS DATABASE,A,Subpart A—General,,§ 111.35 [Reserved],FAA,,,,
14:14:3.0.1.1.2.1.1.9,14,Aeronautics and Space,I,G,111,PART 111—PILOT RECORDS DATABASE,A,Subpart A—General,,§ 111.40 Record retention.,FAA,,,,"(a) The Administrator will maintain a pilot's records in the PRD for the life of the pilot. Any person requesting removal of the records pertaining to an individual pilot must notify the FAA of the pilot's death in a form and manner acceptable to the Administrator.

(b) The notification must include the following:

(1) The full name of the pilot as it appears on his or her pilot certificate;

(2) The pilot's FAA-issued certificate number; and

(3) A certified copy of the individual's certificate of death."
14:14:3.0.1.1.2.2.1.1,14,Aeronautics and Space,I,G,111,PART 111—PILOT RECORDS DATABASE,B,Subpart B—Access to and Evaluation of Records,,§ 111.100 Applicability.,FAA,,,"[86 FR 31060, June 10, 2021, as amended at 86 FR 31067, June 10, 2021]","(a) This subpart prescribes requirements for the following reviewing entities:

(1) Each operator that holds an air carrier or operating certificate issued by the Administrator in accordance with part 119 of this chapter and is authorized to conduct operations under part 121, part 125, or part 135 of this chapter.

(2) Each operator that holds management specifications to operate in accordance with subpart K of part 91 of this chapter.

(3) Each operator that holds a letter of authorization to conduct air tour operations in accordance with § 91.147 of this chapter.

(b) If an operator described in § 111.1(b)(4) or an entity described in § 111.1(b)(5) accesses the PRD to review records in accordance with this subpart, the operator or entity must comply with § 111.120."
14:14:3.0.1.1.2.2.1.2,14,Aeronautics and Space,I,G,111,PART 111—PILOT RECORDS DATABASE,B,Subpart B—Access to and Evaluation of Records,,§ 111.105 Evaluation of pilot records.,FAA,,,,"(a) Except as provided in § 111.115, no reviewing entity may permit an individual to begin service as a pilot until the reviewing entity has evaluated all relevant information in the PRD.

(b) Evaluation must include review of all of the following information pertaining to that pilot:

(1) All FAA records in the PRD as described in § 111.135.

(2) All records in the PRD submitted by a reporting entity.

(3) All motor vehicle driving records obtained in accordance with § 111.110.

(4) The employment history the pilot provides to the PRD in accordance with subpart D of this part. If, upon review of the employment history provided by the pilot and the records described in (b)(2) of this section, a reviewing entity determines that records might be available that the pilot's previous employer has not yet uploaded in the database, the reviewing entity must submit a request to the pilot's previous employer(s) through the PRD to report any applicable records in accordance with the process in § 111.215(b)."
14:14:3.0.1.1.2.2.1.3,14,Aeronautics and Space,I,G,111,PART 111—PILOT RECORDS DATABASE,B,Subpart B—Access to and Evaluation of Records,,§ 111.110 Motor vehicle driving record request.,FAA,,,,"(a) Except as provided in paragraph (d) of this section, no reviewing entity may permit an individual to begin service as a pilot unless the reviewing entity has requested and evaluated all relevant information identified through a National Driver Register (NDR) search set forth in chapter 303 of Title 49 concerning the individual's motor vehicle driving history in accordance with the following:

(1) The reviewing entity must obtain the written consent of that individual, in accordance with § 111.310, before requesting an NDR search for the individual's State motor vehicle driving records;

(2) After obtaining the written consent of the individual, the reviewing entity must submit a request to the NDR to determine whether any State maintains relevant records pertaining to that individual; and

(3) When the NDR search result is returned, if the NDR search result indicates that records exist concerning that individual, the reviewing entity must submit a request for the relevant motor vehicle driving records to each chief driver licensing official of each State identified in the NDR search result.

(b) Each reviewing entity must document in the PRD that the reviewing entity complied with this section, as prescribed at § 111.240.

(c) Upon the Administrator's request, each reviewing entity must provide documentation showing the reviewing entity has conducted the search required by paragraph (a). The reviewing entity must retain this documentation for five years.

(d) This section does not apply to operators described in § 111.100(a)(2) through (3)."
14:14:3.0.1.1.2.2.1.4,14,Aeronautics and Space,I,G,111,PART 111—PILOT RECORDS DATABASE,B,Subpart B—Access to and Evaluation of Records,,§ 111.115 Good faith exception.,FAA,,,,"Reviewing entities may allow an individual to begin service as a pilot without first evaluating records in accordance with § 111.105 only if the reviewing entity—

(a) Made a documented, good faith attempt to access all necessary information maintained in the PRD that the reviewing entity is required to evaluate; and

(b) Received notice from the Administrator that information is missing from the PRD pertaining to the individual's employment history as a pilot."
14:14:3.0.1.1.2.2.1.5,14,Aeronautics and Space,I,G,111,PART 111—PILOT RECORDS DATABASE,B,Subpart B—Access to and Evaluation of Records,,§ 111.120 Pilot consent and right of review.,FAA,,,,"(a) No reviewing entity may retrieve records in the PRD pertaining to any pilot prior to receiving that pilot's written consent authorizing the release of that pilot's information maintained in the PRD.

(b) The consent required in paragraph (a) of this section must be documented by that pilot in accordance with § 111.310.

(c) Any pilot who submits written consent to a reviewing entity in accordance with § 111.310(c) may request a copy of any State motor vehicle driving records the reviewing entity obtained regarding that pilot in accordance with § 111.110. The reviewing entity must provide to the pilot all copies of State motor vehicle driving records obtained within 30 days of receiving the request from that pilot."
14:14:3.0.1.1.2.2.1.6,14,Aeronautics and Space,I,G,111,PART 111—PILOT RECORDS DATABASE,B,Subpart B—Access to and Evaluation of Records,,§ 111.135 FAA records.,FAA,,,,"No reviewing entity may permit an individual to begin service as a pilot unless a responsible person or authorized user has accessed and evaluated all relevant FAA records for that individual in the PRD, including:

(a) Records related to current pilot and medical certificate information, including associated type ratings and information on any limitations to those certificates and ratings.

(b) Records maintained by the Administrator concerning any failed attempt of an individual to pass a practical test required to obtain a certificate or type rating under part 61 of this chapter.

(c) Records related to enforcement actions resulting in a finding by the Administrator, which was not subsequently overturned, of a violation of title 49 of the United States Code or a regulation prescribed or order issued under that title.

(d) Records related to an individual acting as pilot in command or second in command during an aviation accident or incident.

(e) Records related to an individual's pre-employment drug and alcohol testing history and other U.S. Department of Transportation drug and alcohol testing including:

(1) Verified positive drug test results;

(2) Alcohol misuse violations, including confirmed alcohol results of 0.04 or greater; and

(3) Refusals to submit to drug or alcohol testing."
14:14:3.0.1.1.2.3.1.1,14,Aeronautics and Space,I,G,111,PART 111—PILOT RECORDS DATABASE,C,Subpart C—Reporting of Records by Air Carriers and Operators,,§ 111.200 Applicability.,FAA,,,"[86 FR 31060, June 10, 2021, as amended at 86 FR 31067, June 10, 2021]","(a) This subpart prescribes the requirements for reporting records to the PRD about individuals employed as pilots and applies to the following reporting entities:

(1) Each operator that holds an air carrier or operating certificate issued in accordance with part 119 of this chapter and is authorized to conduct operations under part 121, 125, or 135 of this chapter.

(2) Each operator that holds management specifications to operate in accordance with subpart K of part 91 of this chapter.

(3) Each operator that holds a letter of authorization to conduct air tour operations in accordance with § 91.147 of this chapter.

(4) Each operator described in § 111.1(b)(4).

(5) Each entity that conducts public aircraft operations as described in § 111.1(b)(5).

(6) The trustee in bankruptcy of any operator described in this section.

(b) Compliance is required for this subpart as follows:

(1) Compliance with this subpart is required within 30 days of the reporting entity commencing aircraft operations.

(2) Specific compliance dates for records described in § 111.205(b)(2) are set forth in § 111.255."
14:14:3.0.1.1.2.3.1.10,14,Aeronautics and Space,I,G,111,PART 111—PILOT RECORDS DATABASE,C,Subpart C—Reporting of Records by Air Carriers and Operators,,§ 111.240 Verification of motor vehicle driving record search and evaluation.,FAA,,,,"(a) Each operator subject to the requirements of § 111.110 of this part must document in the PRD within 45 days of the pilot's PRD date of hire that the operator met the requirements of § 111.110.

(b) No operator may report any substantive information from State motor vehicle driving records pertaining to any individual obtained in accordance with § 111.110 for inclusion in the PRD."
14:14:3.0.1.1.2.3.1.11,14,Aeronautics and Space,I,G,111,PART 111—PILOT RECORDS DATABASE,C,Subpart C—Reporting of Records by Air Carriers and Operators,,§ 111.245 Special rules for protected records.,FAA,,,,No person may report any pilot record for inclusion in the PRD that was reported by any individual as part of any approved Voluntary Safety Reporting Program for which the FAA has designated reported information as protected in accordance with part 193 of this chapter.
14:14:3.0.1.1.2.3.1.12,14,Aeronautics and Space,I,G,111,PART 111—PILOT RECORDS DATABASE,C,Subpart C—Reporting of Records by Air Carriers and Operators,,§ 111.250 Correction of reported information and dispute resolution.,FAA,,,,"(a) A reporting entity that discovers or is informed of a perceived error or inaccuracy in information previously reported to the PRD must correct that record in the PRD within 10 days of identification, or initiate dispute resolution in accordance with paragraph (b) of this section.

(b) Each reporting entity must—

(1) Initiate investigation of any dispute within 30 days of determining that it does not agree that the record identified is inaccurate.

(2) Provide final disposition within a reasonable amount of time to any request for dispute resolution made by an individual about PRD records.

(3) Document in the PRD the final disposition of any dispute made by a pilot in accordance with this paragraph (b) and § 111.320."
14:14:3.0.1.1.2.3.1.13,14,Aeronautics and Space,I,G,111,PART 111—PILOT RECORDS DATABASE,C,Subpart C—Reporting of Records by Air Carriers and Operators,,§ 111.255 Reporting historical records to PRD.,FAA,,,,"(a) Each operator that holds an air carrier certificate issued in accordance with part 119 of this chapter and is authorized to conduct operations under part 121 or part 135 of this chapter must report to the PRD all historical records kept in accordance with PRIA dating from August 1, 2005 until June 10, 2022, in a form and manner prescribed by the Administrator.

(b) Each operator that holds an operating certificate issued in accordance with part 119 of this chapter and is authorized to conduct operations under part 121, 125, or 135 of this chapter or that holds management specifications to operate in accordance with subpart K of part 91 of this chapter must report to the PRD all historical records kept in accordance with PRIA dating from August 1, 2010, until June 10, 2022, in a form and manner prescribed by the Administrator.

(c) If an operator required to report historical records to the PRD in accordance with this section is appointed a trustee in a bankruptcy proceeding, the trustee must report the operator's historical records.

(d) Compliance for reporting historical records that date on or after January 1, 2015, is required by June 12, 2023. Compliance for records that date before January 1, 2015, is required by September 9, 2024.

(e) An operator or trustee subject to the applicability of this subpart must maintain all historical records reported to the PRD in accordance with paragraphs (a) and (b) of this section for at least five years after reporting those records.

(f) An operator or trustee is not required to report historical records for any individual who is 99 years of age or older on June 10, 2022.

(g)(1)The Administrator may authorize a request for deviation from paragraph (d) of this section based on a determination that a delay in compliance, due to circumstance beyond control of the operatoror trustee reporting historical records, would not adversely affect safety.

(2) A request for deviation from paragraph (d) of this section must include the following information:

(i) The name of the operator or trustee;

(ii) The name of the responsible person;

(iii) The name of the pilot(s) who are the subject of the record;

(iv) Historical record type for which deviation is requested;

(v) Date range of records; and

(vi) Justification for the request for deviation, including a description of the circumstance referenced in (g)(1).

(3) Operators and trustees granted deviation in accordance with this paragraph must continue to retain historical records and respond to requests for such records for the term of that deviation in a form and manner prescribed by the Administrator.

(4) The Administrator may, at any time, terminate a grant of deviation issued under this paragraph."
14:14:3.0.1.1.2.3.1.3,14,Aeronautics and Space,I,G,111,PART 111—PILOT RECORDS DATABASE,C,Subpart C—Reporting of Records by Air Carriers and Operators,,§ 111.205 Reporting requirements.,FAA,,,"[Docket FAA-2020-0246, Amdt. 111-1, 86 FR 31060, 31067, June 10, 2021]","(a) Each reporting entity must provide the information required in paragraph (b) of this section for any individual employed as a pilot beginning on the PRD date of hire for that individual.

(b) Each reporting entity must report the following records to the PRD for each individual employed as a pilot:

(1) All records described in §§ 111.220 through 111.240 generated on or after June 10, 2022;

(2) The PRD date of hire.

(c) No person may enter or cause to be entered into the PRD any information described in § 111.245."
14:14:3.0.1.1.2.3.1.4,14,Aeronautics and Space,I,G,111,PART 111—PILOT RECORDS DATABASE,C,Subpart C—Reporting of Records by Air Carriers and Operators,,§ 111.210 Format for reporting information.,FAA,,,,Each reporting entity must report to the PRD all records required by this subpart for each individual the reporting entity employed as a pilot in a form and manner prescribed by the Administrator.
14:14:3.0.1.1.2.3.1.5,14,Aeronautics and Space,I,G,111,PART 111—PILOT RECORDS DATABASE,C,Subpart C—Reporting of Records by Air Carriers and Operators,,§ 111.215 Method of reporting.,FAA,,,"[Docket FAA-2020-0246, Amdt. 111-1, 86 FR 31060, 31067, June 10, 2021]","(a) Except as provided in paragraph (b) of this section, all records required to be reported to the PRD under this subpart must be reported within 30 days of the effective date of the record, or within 30 days of the record becoming final when the record is a disciplinary action record or a separation from employment record.

(b) Each operator conducting an operation described in § 111.1(b)(4), entity conducting a public aircraft operation, operator conducting an air tour operation under § 91.147, or a trustee for such an operator or entity must either comply with paragraph (a) of this section or report and retain pilot records in accordance with all requirements of this paragraph.

(1) Operators, entities, or trustees listed in this paragraph (b) must report a record described in § 111.225, § 111.230, or § 111.235 to the PRD upon receipt of a request from a reviewing entity within 14 days, unless the record memorializes one or more of the following:

(i) A disciplinary action that resulted in permanent or temporary removal of the pilot from aircraft operations as described in § 111.230, which must be reported in accordance with paragraph (a) of this section.

(ii) A separation from employment action resulting from a termination as described in § 111.235, which must be reported in accordance with paragraph (a) of this section.

(2) If no records are available at time of request from a reviewing entity, the operator, entity, or trustee must provide written confirmation within 14 of the days of the request to the PRD that no records are available.

(3) An operator, entity, or trustee must retain a record eligible to be reported upon request under paragraph (b)(1) of this section for five years from the date of creation, unless the operator or entity already reported that record to the PRD.

(c) For records created before June 10, 2022, and maintained in accordance with PRIA, an operator, entity, or trustee listed in paragraph (b) of this section must continue to maintain all records that would have been provided in response to a PRIA request for five years from the date of creation of the record, and must report that record upon request from a reviewing entity in accordance with paragraph (b)."
14:14:3.0.1.1.2.3.1.6,14,Aeronautics and Space,I,G,111,PART 111—PILOT RECORDS DATABASE,C,Subpart C—Reporting of Records by Air Carriers and Operators,,§ 111.220 Drug and alcohol testing records.,FAA,,,,"(a) Each operator or trustee required to comply with part 120 of this chapter and subject to the applicability of this subpart must report to the PRD the following records for each individual whom the reporting entity has employed as a pilot:

(1) Records concerning drug testing, including—

(i) Any drug test result verified positive by a Medical Review Officer, that the Medical Review Officer and employer must retain in accordance with § 120.111(a)(1) of this chapter and 49 CFR 40.333(a)(1)(ii);

(ii) Any refusal to submit to drug testing or records indicating substituted or adulterated drug test results, which the employer must retain in accordance with 49 CFR 40.333(a)(1)(iii);

(iii) All return-to-duty drug test results verified by a Medical Review Officer, that the employer must retain in accordance with 49 CFR 40.333(a)(1)(ii) or (iii) or (a)(4);

(iv) All follow-up drug test results verified by a Medical Review Officer, which the employer must retain in accordance with 49 CFR 40.333(a)(1)(v).

(2) Records concerning alcohol misuse, including—

(i) A test result with a confirmed breath alcohol concentration of 0.04 or greater, which the employer must retain in accordance with § 120.219(a)(2)(i)(B) of this chapter;

(ii) Any record pertaining to an occurrence of on-duty alcohol use, pre-duty alcohol use, or alcohol use following an accident, which the employer must retain in accordance with § 120.219(a)(2)(i)(D) of this chapter;

(iii) Any refusal to submit to alcohol testing, that the employer must retain in accordance with § 120.219(a)(2)(i)(B) of this chapter and 49 CFR 40.333(a)(1)(iii);

(iv) All return-to-duty alcohol test results, that the employer must retain in accordance with 49 CFR 40.333(a)(1)(i) or (iii) or (a)(4);

(v) All follow-up alcohol test results, which the employer must retain in accordance with 49 CFR 40.333(a)(1)(v).

(b) Each record reported to the PRD in accordance with paragraph (a) of this section must include the following:

(1) In the case of a drug or alcohol test result:

(i) The type of test administered;

(ii) The date the test was administered; and

(iii) The result of the test.

(2) In the case of alcohol misuse, as described in paragraph (a)(2)(ii) of this section:

(i) The type of each alcohol misuse violation;

(ii) The date of each alcohol misuse violation.

(c) In addition to the requirements of §§ 120.113(d)(3) and 120.221(c), operators required to report in accordance with this section must report records within 30 days of the following occurrences, as applicable:

(1) The date of verification of the drug test result;

(2) The date of the alcohol test result;

(3) The date of the refusal to submit to testing; or

(4) The date of the alcohol misuse occurrence."
14:14:3.0.1.1.2.3.1.7,14,Aeronautics and Space,I,G,111,PART 111—PILOT RECORDS DATABASE,C,Subpart C—Reporting of Records by Air Carriers and Operators,,"§ 111.225 Training, qualification, and proficiency records.",FAA,,,,"(a) Except as provided in paragraph (b) of this section, each reporting entity must provide to the PRD the following records for each individual whom the reporting entity has employed as a pilot:

(1) Records establishing an individual's compliance with FAA-required training, qualifications, and proficiency events, which the reporting entity maintains pursuant to § 91.1027(a)(3), § 121.683, § 125.401 or § 135.63(a)(4) of this chapter, as applicable, including comments and evaluations made by a check pilot or evaluator; and

(2) Other records the reporting entity maintains documenting an individual's compliance with FAA or employer-required training, checking, testing, proficiency, or other events related to pilot performance concerning the training, qualifications, proficiency, and professional competence of the individual, including any comments and evaluations made by a check pilot or evaluator.

(b) No person may report any of the following information for inclusion in the PRD:

(1) Records related to flight time, duty time, and rest time.

(2) Records demonstrating compliance with physical examination requirements or any other protected medical records.

(3) Records documenting recent flight experience.

(4) Records identified in § 111.245.

(c) Each record reported to the PRD in accordance with paragraph (a) of this section must include:

(1) Date of the event;

(2) Aircraft type, if applicable;

(3) Duty position of the pilot, if applicable;

(4) Training program approval part and subpart of this chapter, as applicable;

(5) Crewmember training and qualification curriculum and category of training as reflected in either a FAA-approved or employer-mandated training program;

(6) Result of the event (satisfactory or unsatisfactory);

(7) Comments of check pilot or evaluator, if applicable under part 91, 121, 125, or 135 of this chapter. For unsatisfactory events, the tasks or maneuvers considered unsatisfactory must be included.

(d) An operator, entity, or trustee that complies with § 111.215(b) must report records in accordance with paragraphs (a) through (c) of this section upon request, if that operator or entity possesses those records.

(e)(1) Each reporting entity must provide a record within 30 days of creating that record, in accordance with § 111.215(a), unless the reporting entity is an operator, entity, or trustee complying with § 111.215(b).

(2) An operator, entity, or trustee complying with § 111.215(b) must provide records described in this section or a statement that it does not have any records described in this section within 14 days of receiving a request from a reviewing entity."
14:14:3.0.1.1.2.3.1.8,14,Aeronautics and Space,I,G,111,PART 111—PILOT RECORDS DATABASE,C,Subpart C—Reporting of Records by Air Carriers and Operators,,§ 111.230 Final disciplinary action records.,FAA,,,,"(a) Except as provided in paragraph (b) of this section, each reporting entity must provide to the PRD any final disciplinary action record pertaining to pilot performance with respect to an individual whom the reporting entity has employed as a pilot.

(b) No person may report to the PRD any record of disciplinary action that was subsequently overturned because the event prompting the action did not occur or the pilot was not at fault as determined by—

(1) A documented agreement between the employer and the pilot; or

(2) The official and final decision or order of any panel or person with authority to review employment disputes, or by any court of law.

(c) If a reporting entity receives notice that any disciplinary action record reported to the PRD under paragraph (a) of this section was overturned in accordance with paragraph (b), that entity must correct the pilot's PRD record in accordance with § 111.250 within 10 days.

(d) Each final disciplinary action record that must be reported to the PRD under paragraph (a) of this section must include the following information:

(1) The type of disciplinary action taken by the employer, including written warning, suspension, or termination;

(2) Whether the disciplinary action resulted in permanent or temporary removal of the pilot from aircraft operations;

(3) The date the disciplinary action occurred; and

(4) Whether there are additional documents available that are relevant to the record.

(e) An operator, entity, or trustee complying with § 111.215(b) must report records described in paragraphs (a) through (d) of this section upon request, unless the disciplinary action resulted in permanent or temporary removal of the pilot from aircraft operations. If the disciplinary action resulted in permanent or temporary removal of the pilot from aircraft operations, the operator, entity, or trustee must report the record in accordance with § 111.215(a).

(f)(1) A reporting entity must provide records of final disciplinary actions no later than 30 days after the action is final, unless the reporting entity is an operator, entity or trustee complying with § 111.215(b).

(2) An operator, entity or trustee complying with § 111.215(b) must report records described in this section, or state that it does not have any applicable records, within 14 days of receiving a request from a reviewing entity.

(g) Each reporting entity must:

(1) Retain documents relevant to the record reported under paragraph (a) of this section for five years, if available; and

(2) Provide such documents upon request within 14 days to:

(i) A reviewing entity; or

(ii) The pilot that is the subject of the record."
14:14:3.0.1.1.2.3.1.9,14,Aeronautics and Space,I,G,111,PART 111—PILOT RECORDS DATABASE,C,Subpart C—Reporting of Records by Air Carriers and Operators,,§ 111.235 Final separation from employment records.,FAA,,,,"(a) Except as provided in paragraph (b) of this section, each reporting entity must provide to the PRD the following records for each individual whom the reporting entity has employed as a pilot:

(1) Records concerning separation from employment kept pursuant to § 91.1027(a)(3), § 121.683, § 125.401 or § 135.63(a)(4) of this chapter; and

(2) Records pertaining to pilot performance kept concerning separation from employment for each pilot that it employs.

(b) No person may report to the PRD any record regarding separation from employment that was subsequently overturned because the event prompting the action did not occur or the pilot was not at fault as determined by—

(1) A documented agreement between the employer and the pilot; or

(2) The official and final decision or order of any panel or individual given authority to review employment disputes, or by any court of law.

(c) If a reporting entity receives notice that any separation from employment record reported to the PRD under paragraph (a) of this section was overturned in accordance with paragraph (b) of this section, that entity must correct the pilot's PRD record in accordance with § 111.250 within 10 days.

(d) Each separation from employment action record that must be reported to the PRD in accordance with paragraph (a) of this section must include a statement of the purpose for the separation from employment action, including:

(1) Whether the separation resulted from a termination as a result of pilot performance, including professional disqualification;

(2) Whether the separation is based on another reason, including but not limited to physical (medical) disqualification, employer-initiated separation not related to pilot performance, or any resignation, including retirement;

(3) The date of separation from employment; and

(4) Whether there are additional documents available that are relevant to the record.

(e) An operator, entity, or trustee complying with § 111.215(b) must report the records described in paragraphs (a) through (d) of this section upon request, unless the separation from employment action resulted from a termination. If the separation from employment record resulted from a termination, the operator, entity, or trustee must report the record in accordance with § 111.215(a).

(f)(1) A reporting entity must provide any records of separation from employment actions no later than 30 days after the date of separation from employment is final, unless the reporting entity is an operator, entity, or trustee complying with § 111.215(b).

(2) An operator, entity, or trustee complying with § 111.215(b) must report records described in this section or state that it does not have any applicable records within 14 days of receiving a request from a reviewing entity.

(g) Each reporting entity must:

(1) Retain documents relevant to the record reported under paragraph (a) of this section for five years, if available; and

(2) Provide such documents upon request within 14 days to:

(i) A reviewing entity; or

(ii) The pilot that is the subject of the record."
14:14:3.0.1.1.2.4.1.1,14,Aeronautics and Space,I,G,111,PART 111—PILOT RECORDS DATABASE,D,Subpart D—Pilot Access and Responsibilities,,§ 111.300 Applicability.,FAA,,,,"This subpart applies to each individual who is employed as a pilot by, or is seeking employment as a pilot with, an operator or entity subject to the applicability of this part, as set forth in § 111.1."
14:14:3.0.1.1.2.4.1.2,14,Aeronautics and Space,I,G,111,PART 111—PILOT RECORDS DATABASE,D,Subpart D—Pilot Access and Responsibilities,,§ 111.305 Application for database access.,FAA,,,,"(a) A pilot must request electronic access to the PRD by submitting an application in a form and manner acceptable to the Administrator. Except as provided in § 111.315(c), electronic access to the PRD is required when—

(1) The pilot seeks to review and obtain a copy of that pilot's own comprehensive PRD record;

(2) The pilot gives consent to a particular operator to access that pilot's comprehensive PRD record; or

(3) The pilot exercises any other privileges provided by this part.

(b) The application required in paragraph (a) of this section must include, at a minimum, the following information:

(1) The pilot's full name as it appears on his or her pilot certificate.

(2) The pilot's FAA-issued certificate number.

(3) A current mailing address and telephone number.

(4) An electronic mail address.

(5) Any additional information that the Administrator might request to verify the identity of the pilot requesting access to the PRD.

(c) The application required in paragraph (a) of this section must be submitted at least 7 days before the pilot seeks to access the PRD."
14:14:3.0.1.1.2.4.1.3,14,Aeronautics and Space,I,G,111,PART 111—PILOT RECORDS DATABASE,D,Subpart D—Pilot Access and Responsibilities,,§ 111.310 Written consent.,FAA,,,,"(a) Before any operator may access a pilot's records in the PRD, that pilot must apply for access to the PRD in accordance with § 111.305 and provide written consent to the FAA for release of that pilot's records to the operator, in a form and manner acceptable to the Administrator.

(b) Provision of consent must include an affirmation that the employment history of the pilot for five years preceding the date of consent is accurate and complete. If the pilot finds the employment history is not complete, the pilot must update the employment history to list all past employers.

(c) Before an operator submits a request to the NDR for an individual's motor vehicle driving record for purposes of compliance with § 111.110, the individual must provide written consent specific to the NDR search."
14:14:3.0.1.1.2.4.1.4,14,Aeronautics and Space,I,G,111,PART 111—PILOT RECORDS DATABASE,D,Subpart D—Pilot Access and Responsibilities,,§ 111.315 Pilot right of review.,FAA,,,,"(a) Once a pilot has received electronic access in accordance with § 111.305, the pilot may access the PRD to review all records pertaining to that pilot.

(b) A pilot who submits written consent to a reviewing entity in accordance with § 111.310(c) may request a copy of any State motor vehicle driving records obtained by the reviewing entity in accordance with § 111.110.

(c) A pilot may review all records contained in the PRD pertaining to that pilot, without accessing the PRD and without obtaining electronic access issued in accordance with § 111.305, upon submission of a form provided by the Administrator to confirm the pilot's identity."
14:14:3.0.1.1.2.4.1.5,14,Aeronautics and Space,I,G,111,PART 111—PILOT RECORDS DATABASE,D,Subpart D—Pilot Access and Responsibilities,,§ 111.320 Reporting errors and requesting corrections.,FAA,,,,A pilot who identifies an error or inaccuracy in that pilot's PRD records must report the error or inaccuracy to the PRD in a form and manner acceptable to the Administrator.
21:21:2.0.1.1.11.1.1.1,21,Food and Drugs,I,B,111,"PART 111—CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS",A,Subpart A—General Provisions,,§ 111.1 Who is subject to this part?,FDA,,,,"(a) Except as provided by paragraph (b) of this section, you are subject to this part if you manufacture, package, label, or hold a dietary supplement, including:

(1) A dietary supplement you manufacture but that is packaged or labeled by another person; and

(2) A dietary supplement imported or offered for import in any State or territory of the United States, the District of Columbia, or the Commonwealth of Puerto Rico.

(b) The requirements pertaining to holding dietary supplements do not apply to you if you are holding those dietary supplements at a retail establishment for the sole purpose of direct retail sale to individual consumers. A retail establishment does not include a warehouse or other storage facility for a retailer or a warehouse or other storage facility that sells directly to individual consumers."
21:21:2.0.1.1.11.1.1.2,21,Food and Drugs,I,B,111,"PART 111—CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS",A,Subpart A—General Provisions,,§ 111.3 What definitions apply to this part?,FDA,,,,"The definitions and interpretations of terms in section 201 of the Federal Food, Drug, and Cosmetic Act (the act) apply to such terms when used in this part. For the purpose of this part, the following definitions also apply:

Actual yield  means the quantity that is actually produced at any appropriate step of manufacture or packaging of a particular dietary supplement.

Batch  means a specific quantity of a dietary supplement that is uniform, that is intended to meet specifications for identity, purity, strength, and composition, and that is produced during a specified time period according to a single manufacturing record during the same cycle of manufacture.

Batch number, lot number, or control number  means any distinctive group of letters, numbers, or symbols, or any combination of them, from which the complete history of the manufacturing, packaging, labeling, and/or holding of a batch or lot of dietary supplements can be determined.

Component  means any substance intended for use in the manufacture of a dietary supplement, including those that may not appear in the finished batch of the dietary supplement. Component includes dietary ingredients (as described in section 201(ff) of the act) and other ingredients.

Contact surface  means any surface that contacts a component or dietary supplement, and those surfaces from which drainage onto the component or dietary supplement, or onto surfaces that contact the component or dietary supplement, occurs during the normal course of operations. Examples of contact surfaces include containers, utensils, tables, contact surfaces of equipment, and packaging.

Ingredient  means any substance that is used in the manufacture of a dietary supplement and that is intended to be present in the finished batch of the dietary supplement. An ingredient includes, but is not necessarily limited to, a dietary ingredient as defined in section 201(ff) of the act.

In-process material  means any material that is fabricated, compounded, blended, ground, extracted, sifted, sterilized, derived by chemical reaction, or processed in any other way for use in the manufacture of a dietary supplement.

Lot  means a batch, or a specific identified portion of a batch, that is uniform and that is intended to meet specifications for identity, purity, strength, and composition; or, in the case of a dietary supplement produced by continuous process, a specific identified amount produced in a specified unit of time or quantity in a manner that is uniform and that is intended to meet specifications for identity, purity, strength, and composition.

Microorganisms  means yeasts, molds, bacteria, viruses, and other similar microscopic organisms having public health or sanitary concern. This definition includes species that:

(1) May have public health significance;

(2) May cause a component or dietary supplement to decompose;

(3) Indicate that the component or dietary supplement is contaminated with filth; or

(4) Otherwise may cause the component or dietary supplement to be adulterated.

Must  is used to state a requirement.

Pest  means any objectionable insect or other animal including birds, rodents, flies, mites, and larvae.

Physical plant  means all or any part of a building or facility used for or in connection with manufacturing, packaging, labeling, or holding a dietary supplement.

Product complaint  means any communication that contains any allegation, written, electronic, or oral, expressing concern, for any reason, with the quality of a dietary supplement, that could be related to current good manufacturing practice. Examples of product complaints are: Foul odor, off taste, illness or injury, disintegration time, color variation, tablet size or size variation, under-filled container, foreign material in a dietary supplement container, improper packaging, mislabeling, or dietary supplements that are superpotent, subpotent, or contain the wrong ingredient, or contain a drug or other contaminant (e.g., bacteria, pesticide, mycotoxin, glass, lead).

Quality  means that the dietary supplement consistently meets the established specifications for identity, purity, strength, and composition, and limits on contaminants, and has been manufactured, packaged, labeled, and held under conditions to prevent adulteration under section 402(a)(1), (a)(2), (a)(3), and (a)(4) of the act.

Quality control  means a planned and systematic operation or procedure for ensuring the quality of a dietary supplement.

Quality control personnel  means any person, persons, or group, within or outside of your organization, who you designate to be responsible for your quality control operations.

Representative sample  means a sample that consists of an adequate number of units that are drawn based on rational criteria, such as random sampling, and that are intended to ensure that the sample accurately portrays the material being sampled.

Reprocessing  means using, in the manufacture of a dietary supplement, clean, uncontaminated components or dietary supplements that have been previously removed from manufacturing and that have been made suitable for use in the manufacture of a dietary supplement.

Reserve sample  means a representative sample of product that is held for a designated period of time.

Sanitize  means to adequately treat cleaned equipment, containers, utensils, or any other cleaned contact surface by a process that is effective in destroying vegetative cells of microorganisms of public health significance, and in substantially reducing numbers of other microorganisms, but without adversely affecting the product or its safety for the consumer.

Theoretical yield  means the quantity that would be produced at any appropriate step of manufacture or packaging of a particular dietary supplement, based upon the quantity of components or packaging to be used, in the absence of any loss or error in actual production.

Water activity  (a w ) is a measure of the free moisture in a component or dietary supplement and is the quotient of the water vapor pressure of the substance divided by the vapor pressure of pure water at the same temperature.

We  means the U.S. Food and Drug Administration (FDA).

You  means a person who manufactures, packages, labels, or holds dietary supplements."
21:21:2.0.1.1.11.1.1.3,21,Food and Drugs,I,B,111,"PART 111—CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS",A,Subpart A—General Provisions,,§ 111.5 Do other statutory provisions and regulations apply?,FDA,,,"[72 FR 34942, June 25, 2007, as amended at 80 FR 74352, Nov. 27, 2015]","In addition to this part, you must comply with other applicable statutory provisions and regulations under the act related to dietary supplements. For importers of dietary supplements and dietary supplement components, the regulation on foreign supplier verification programs can be found in subpart L of part 1 of this chapter."
21:21:2.0.1.1.11.10.1.1,21,Food and Drugs,I,B,111,"PART 111—CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS",J,Subpart J—Production and Process Control System: Requirements for Laboratory Operations,,§ 111.303 What are the requirements under this subpart J for written procedures?,FDA,,,,"You must establish and follow written procedures for laboratory operations, including written procedures for the tests and examinations that you conduct to determine whether specifications are met."
21:21:2.0.1.1.11.10.1.2,21,Food and Drugs,I,B,111,"PART 111—CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS",J,Subpart J—Production and Process Control System: Requirements for Laboratory Operations,,§ 111.310 What are the requirements for the laboratory facilities that you use?,FDA,,,,"You must use adequate laboratory facilities to perform whatever testing and examinations are necessary to determine whether:

(a) Components that you use meet specifications;

(b) In-process specifications are met as specified in the master manufacturing record; and

(c) Dietary supplements that you manufacture meet specifications."
21:21:2.0.1.1.11.10.1.3,21,Food and Drugs,I,B,111,"PART 111—CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS",J,Subpart J—Production and Process Control System: Requirements for Laboratory Operations,,§ 111.315 What are the requirements for laboratory control processes?,FDA,,,,"You must establish and follow laboratory control processes that are reviewed and approved by quality control personnel, including the following:

(a) Use of criteria for establishing appropriate specifications;

(b) Use of sampling plans for obtaining representative samples, in accordance with subpart E of this part, of:

(1) Components, packaging, and labels;

(2) In-process materials;

(3) Finished batches of dietary supplements;

(4) Product that you receive for packaging or labeling as a dietary supplement (and for distribution rather than for return to the supplier); and

(5) Packaged and labeled dietary supplements.

(c) Use of criteria for selecting appropriate examination and testing methods;

(d) Use of criteria for selecting standard reference materials used in performing tests and examinations; and

(e) Use of test methods and examinations in accordance with established criteria."
21:21:2.0.1.1.11.10.1.4,21,Food and Drugs,I,B,111,"PART 111—CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS",J,Subpart J—Production and Process Control System: Requirements for Laboratory Operations,,§ 111.320 What requirements apply to laboratory methods for testing and examination?,FDA,,,,"(a) You must verify that the laboratory examination and testing methodologies are appropriate for their intended use.

(b) You must identify and use an appropriate scientifically valid method for each established specification for which testing or examination is required to determine whether the specification is met."
21:21:2.0.1.1.11.10.1.5,21,Food and Drugs,I,B,111,"PART 111—CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS",J,Subpart J—Production and Process Control System: Requirements for Laboratory Operations,,"§ 111.325 Under this subpart J, what records must you make and keep?",FDA,,,,"(a) You must make and keep records required under this subpart J in accordance with subpart P of this part.

(b) You must make and keep the following records:

(1) Written procedures for laboratory operations, including written procedures for the tests and examinations that you conduct to determine whether specifications are met;

(2) Documentation that laboratory methodology established in accordance with this subpart J is followed.

(i) The person who conducts the testing and examination must document, at the time of performance, that laboratory methodology established in accordance with this subpart J is followed.

(ii) The documentation for laboratory tests and examinations must include the results of the testing and examination."
21:21:2.0.1.1.11.11.1.1,21,Food and Drugs,I,B,111,"PART 111—CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS",K,Subpart K—Production and Process Control System: Requirements for Manufacturing Operations,,§ 111.353 What are the requirements under this subpart K for written procedures?,FDA,,,,You must establish and follow written procedures for manufacturing operations.
21:21:2.0.1.1.11.11.1.2,21,Food and Drugs,I,B,111,"PART 111—CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS",K,Subpart K—Production and Process Control System: Requirements for Manufacturing Operations,,§ 111.355 What are the design requirements for manufacturing operations?,FDA,,,,You must design or select manufacturing processes to ensure that product specifications are consistently met.
21:21:2.0.1.1.11.11.1.3,21,Food and Drugs,I,B,111,"PART 111—CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS",K,Subpart K—Production and Process Control System: Requirements for Manufacturing Operations,,§ 111.360 What are the requirements for sanitation?,FDA,,,,You must conduct all manufacturing operations in accordance with adequate sanitation principles.
21:21:2.0.1.1.11.11.1.4,21,Food and Drugs,I,B,111,"PART 111—CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS",K,Subpart K—Production and Process Control System: Requirements for Manufacturing Operations,,§ 111.365 What precautions must you take to prevent contamination?,FDA,,,,"You must take all the necessary precautions during the manufacture of a dietary supplement to prevent contamination of components or dietary supplements. These precautions include:

(a) Performing manufacturing operations under conditions and controls that protect against the potential for growth of microorganisms and the potential for contamination;

(b) Washing or cleaning components that contain soil or other contaminants;

(c) Using water that, at a minimum, complies with the applicable Federal, State, and local requirements and does not contaminate the dietary supplement when the water may become a component of the finished batch of dietary supplement;

(d) Performing chemical, microbiological, or other testing, as necessary to prevent the use of contaminated components;

(e) Sterilizing, pasteurizing, freezing, refrigerating, controlling hydrogen-ion concentration (pH), controlling humidity, controlling water activity (a w ), or using any other effective means to remove, destroy, or prevent the growth of microorganisms and prevent decomposition;

(f) Holding components and dietary supplements that can support the rapid growth of microorganisms of public health significance in a manner that prevents the components and dietary supplements from becoming adulterated;

(g) Identifying and holding any components or dietary supplements, for which a material review and disposition decision is required, in a manner that protects components or dietary supplements that are not under a material review against contamination and mixups with those that are under a material review;

(h) Performing mechanical manufacturing steps (such as cutting, sorting, inspecting, shredding, drying, grinding, blending, and sifting) by any effective means to protect the dietary supplements against contamination, by, for example:

(1) Cleaning and sanitizing contact surfaces;

(2) Using temperature controls; and

(3) Using time controls.

(i) Using effective measures to protect against the inclusion of metal or other foreign material in components or dietary supplements, by, for example:

(1) Filters or strainers,

(2) Traps,

(3) Magnets, or

(4) Electronic metal detectors.

(j) Segregating and identifying all containers for a specific batch of dietary supplements to identify their contents and, when necessary, the phase of manufacturing; and

(k) Identifying all processing lines and major equipment used during manufacturing to indicate their contents, including the name of the dietary supplement and the specific batch or lot number and, when necessary, the phase of manufacturing."
21:21:2.0.1.1.11.11.1.5,21,Food and Drugs,I,B,111,"PART 111—CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS",K,Subpart K—Production and Process Control System: Requirements for Manufacturing Operations,,§ 111.370 What requirements apply to rejected dietary supplements?,FDA,,,,"You must clearly identify, hold, and control under a quarantine system for appropriate disposition any dietary supplement that is rejected and unsuitable for use in manufacturing, packaging, or labeling operations."
21:21:2.0.1.1.11.11.1.6,21,Food and Drugs,I,B,111,"PART 111—CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS",K,Subpart K—Production and Process Control System: Requirements for Manufacturing Operations,,"§ 111.375 Under this subpart K, what records must you make and keep?",FDA,,,,"(a) You must make and keep records required under this subpart K in accordance with subpart P of this part.

(b) You must make and keep records of the written procedures for manufacturing operations."
21:21:2.0.1.1.11.12.1.1,21,Food and Drugs,I,B,111,"PART 111—CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS",L,Subpart L—Production and Process Control System: Requirements for Packaging and Labeling Operations,,§ 111.403 What are the requirements under this subpart L for written procedures?,FDA,,,,You must establish and follow written procedures for packaging and labeling operations.
21:21:2.0.1.1.11.12.1.2,21,Food and Drugs,I,B,111,"PART 111—CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS",L,Subpart L—Production and Process Control System: Requirements for Packaging and Labeling Operations,,§ 111.410 What requirements apply to packaging and labels?,FDA,,,,"(a) You must take necessary actions to determine whether packaging for dietary supplements meets specifications so that the condition of the packaging will ensure the quality of your dietary supplements;

(b) You must control the issuance and use of packaging and labels and reconciliation of any issuance and use discrepancies. Label reconciliation is not required for cut or rolled labels if a 100-percent examination for correct labels is performed by appropriate electronic or electromechanical equipment during or after completion of finishing operations; and

(c) You must examine, before packaging and labeling operations, packaging and labels for each batch of dietary supplement to determine whether the packaging and labels conform to the master manufacturing record; and

(d) You must be able to determine the complete manufacturing history and control of the packaged and labeled dietary supplement through distribution."
21:21:2.0.1.1.11.12.1.3,21,Food and Drugs,I,B,111,"PART 111—CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS",L,Subpart L—Production and Process Control System: Requirements for Packaging and Labeling Operations,,"§ 111.415 What requirements apply to filling, assembling, packaging, labeling, and related operations?",FDA,,,,"You must fill, assemble, package, label, and perform other related operations in a way that ensures the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record. You must do this using any effective means, including the following:

(a) Cleaning and sanitizing all filling and packaging equipment, utensils, and dietary supplement packaging, as appropriate;

(b) Protecting manufactured dietary supplements from contamination, particularly airborne contamination;

(c) Using sanitary handling procedures;

(d) Establishing physical or spatial separation of packaging and label operations from operations on other components and dietary supplements to prevent mixups;

(e) Identifying, by any effective means, filled dietary supplement containers that are set aside and held in unlabeled condition for future label operations, to prevent mixups;

(f) Assigning a batch, lot, or control number to:

(1) Each lot of packaged and labeled dietary supplement from a finished batch of dietary supplement; and,

(2) Each lot of dietary supplement, from a finished batch of dietary supplement, that you distribute to another person for packaging or labeling.

(g) Examining a representative sample of each batch of the packaged and labeled dietary supplement to determine whether the dietary supplement meets specifications established in accordance with § 111.70(g); and

(h) Suitably disposing of labels and packaging for dietary supplements that are obsolete or incorrect to ensure that they are not used in any future packaging and label operations."
21:21:2.0.1.1.11.12.1.4,21,Food and Drugs,I,B,111,"PART 111—CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS",L,Subpart L—Production and Process Control System: Requirements for Packaging and Labeling Operations,,§ 111.420 What requirements apply to repackaging and relabeling?,FDA,,,,"(a) You may repackage or relabel dietary supplements only after quality control personnel have approved such repackaging or relabeling.

(b) You must examine a representative sample of each batch of repackaged or relabeled dietary supplements to determine whether the repackaged or relabeled dietary supplements meet all specifications established in accordance with § 111.70(g).

(c) Quality control personnel must approve or reject each batch of repackaged or relabeled dietary supplement prior to its release for distribution."
21:21:2.0.1.1.11.12.1.5,21,Food and Drugs,I,B,111,"PART 111—CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS",L,Subpart L—Production and Process Control System: Requirements for Packaging and Labeling Operations,,§ 111.425 What requirements apply to a packaged and labeled dietary supplement that is rejected for distribution?,FDA,,,,"You must clearly identify, hold, and control under a quarantine system for appropriate disposition any packaged and labeled dietary supplement that is rejected for distribution."
21:21:2.0.1.1.11.12.1.6,21,Food and Drugs,I,B,111,"PART 111—CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS",L,Subpart L—Production and Process Control System: Requirements for Packaging and Labeling Operations,,"§ 111.430 Under this subpart L, what records must you make and keep?",FDA,,,,"(a) You must make and keep records required under this subpart L in accordance with subpart P of this part.

(b) You must make and keep records of the written procedures for packaging and labeling operations."
21:21:2.0.1.1.11.13.1.1,21,Food and Drugs,I,B,111,"PART 111—CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS",M,Subpart M—Holding and Distributing,,§ 111.453 What are the requirements under this subpart for M written procedures?,FDA,,,,You must establish and follow written procedures for holding and distributing operations.
21:21:2.0.1.1.11.13.1.2,21,Food and Drugs,I,B,111,"PART 111—CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS",M,Subpart M—Holding and Distributing,,"§ 111.455 What requirements apply to holding components, dietary supplements, packaging, and labels?",FDA,,,,"(a) You must hold components and dietary supplements under appropriate conditions of temperature, humidity, and light so that the identity, purity, strength, and composition of the components and dietary supplements are not affected.

(b) You must hold packaging and labels under appropriate conditions so that the packaging and labels are not adversely affected.

(c) You must hold components, dietary supplements, packaging, and labels under conditions that do not lead to the mixup, contamination, or deterioration of components, dietary supplements, packaging, and labels."
21:21:2.0.1.1.11.13.1.3,21,Food and Drugs,I,B,111,"PART 111—CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS",M,Subpart M—Holding and Distributing,,§ 111.460 What requirements apply to holding in-process material?,FDA,,,,"(a) You must identify and hold in-process material under conditions that protect against mixup, contamination, and deterioration.

(b) You must hold in-process material under appropriate conditions of temperature, humidity, and light."
21:21:2.0.1.1.11.13.1.4,21,Food and Drugs,I,B,111,"PART 111—CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS",M,Subpart M—Holding and Distributing,,§ 111.465 What requirements apply to holding reserve samples of dietary supplements?,FDA,,,,"(a) You must hold reserve samples of dietary supplements in a manner that protects against contamination and deterioration. This includes:

(1) Holding the reserve samples under conditions consistent with product labels or, if no storage conditions are recommended on the label, under ordinary storage conditions; and

(2) Using the same container-closure system in which the packaged and labeled dietary supplement is distributed, or if distributing dietary supplements to be packaged and labeled, using a container-closure system that provides essentially the same characteristics to protect against contamination or deterioration as the one in which you distribute the dietary supplement for packaging and labeling elsewhere.

(b) You must retain reserve samples for 1 year past the shelf life date (if shelf life dating is used), or for 2 years from the date of distribution of the last batch of dietary supplements associated with the reserve samples, for use in appropriate investigations."
21:21:2.0.1.1.11.13.1.5,21,Food and Drugs,I,B,111,"PART 111—CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS",M,Subpart M—Holding and Distributing,,§ 111.470 What requirements apply to distributing dietary supplements?,FDA,,,,You must distribute dietary supplements under conditions that will protect the dietary supplements against contamination and deterioration.
21:21:2.0.1.1.11.13.1.6,21,Food and Drugs,I,B,111,"PART 111—CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS",M,Subpart M—Holding and Distributing,,"§ 111.475 Under this subpart M, what records must you make and keep?",FDA,,,,"(a) You must make and keep records required under this subpart M in accordance with subpart P of this part.

(b) You must make and keep the following records:

(1) Written procedures for holding and distributing operations; and

(2) Records of product distribution."
21:21:2.0.1.1.11.14.1.1,21,Food and Drugs,I,B,111,"PART 111—CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS",N,Subpart N—Returned Dietary Supplements,,§ 111.503 What are the requirements under this subpart N for written procedures?,FDA,,,,You must establish and follow written procedures to fulfill the requirements of this subpart.
21:21:2.0.1.1.11.14.1.2,21,Food and Drugs,I,B,111,"PART 111—CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS",N,Subpart N—Returned Dietary Supplements,,§ 111.510 What requirements apply when a returned dietary supplement is received?,FDA,,,,You must identify and quarantine returned dietary supplements until quality control personnel conduct a material review and make a disposition decision.
21:21:2.0.1.1.11.14.1.3,21,Food and Drugs,I,B,111,"PART 111—CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS",N,Subpart N—Returned Dietary Supplements,,"§ 111.515 When must a returned dietary supplement be destroyed, or otherwise suitably disposed of?",FDA,,,,"You must destroy, or otherwise suitably dispose of, any returned dietary supplement unless the outcome of a material review and disposition decision is that quality control personnel do the following:

(a) Approve the salvage of the returned dietary supplement for redistribution or

(b) Approve the returned dietary supplement for reprocessing."
21:21:2.0.1.1.11.14.1.4,21,Food and Drugs,I,B,111,"PART 111—CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS",N,Subpart N—Returned Dietary Supplements,,§ 111.520 When may a returned dietary supplement be salvaged?,FDA,,,,You may salvage a returned dietary supplement only if quality control personnel conduct a material review and make a disposition decision to allow the salvage.
21:21:2.0.1.1.11.14.1.5,21,Food and Drugs,I,B,111,"PART 111—CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS",N,Subpart N—Returned Dietary Supplements,,§ 111.525 What requirements apply to a returned dietary supplement that quality control personnel approve for reprocessing?,FDA,,,,"(a) You must ensure that any returned dietary supplements that are reprocessed meet all product specifications established in accordance with § 111.70(e); and

(b) Quality control personnel must approve or reject the release for distribution of any returned dietary supplement that is reprocessed."
21:21:2.0.1.1.11.14.1.6,21,Food and Drugs,I,B,111,"PART 111—CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS",N,Subpart N—Returned Dietary Supplements,,§ 111.530 When must an investigation be conducted of your manufacturing processes and other batches?,FDA,,,,"If the reason for a dietary supplement being returned implicates other batches, you must conduct an investigation of your manufacturing processes and each of those other batches to determine compliance with specifications."
21:21:2.0.1.1.11.14.1.7,21,Food and Drugs,I,B,111,"PART 111—CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS",N,Subpart N—Returned Dietary Supplements,,"§ 111.535 Under this subpart N, what records must you make and keep?",FDA,,,,"(a) You must make and keep records required under this subpart N in accordance with subpart P of this part.

(b) You must make and keep the following records:

(1) Written procedures for fulfilling the requirements of this subpart N.

(2) Any material review and disposition decision on a returned dietary supplement;

(3) The results of any testing or examination conducted to determine compliance with product specifications established under § 111.70(e); and,

(4) Documentation of the reevaluation by quality control personnel of any dietary supplement that is reprocessed and the determination by quality control personnel of whether the reprocessed dietary supplement meets product specifications established in accordance with § 111.70(e)."
21:21:2.0.1.1.11.15.1.1,21,Food and Drugs,I,B,111,"PART 111—CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS",O,Subpart O—Product Complaints,,§ 111.553 What are the requirements under this subpart O for written procedures?,FDA,,,,You must establish and follow written procedures to fulfill the requirements of this subpart O.
21:21:2.0.1.1.11.15.1.2,21,Food and Drugs,I,B,111,"PART 111—CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS",O,Subpart O—Product Complaints,,§ 111.560 What requirements apply to the review and investigation of a product complaint?,FDA,,,,"(a) A qualified person must:

(1) Review all product complaints to determine whether the product complaint involves a possible failure of a dietary supplement to meet any of its specifications, or any other requirements of this part 111, including those specifications and other requirements that, if not met, may result in a risk of illness or injury; and

(2) Investigate any product complaint that involves a possible failure of a dietary supplement to meet any of its specifications, or any other requirements of this part, including those specifications and other requirements that, if not met, may result in a risk of illness or injury.

(b) Quality control personnel must review and approve decisions about whether to investigate a product complaint and review and approve the findings and followup action of any investigation performed.

(c) The review and investigation of the product complaint by a qualified person, and the review by quality control personnel about whether to investigate a product complaint, and the findings and followup action of any investigation performed, must extend to all relevant batches and records."
21:21:2.0.1.1.11.15.1.3,21,Food and Drugs,I,B,111,"PART 111—CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS",O,Subpart O—Product Complaints,,"§ 111.570 Under this subpart O, what records must you make and keep?",FDA,,,,"(a) You must make and keep the records required under this subpart O in accordance with subpart P of this part.

(b) You must make and keep the following records:

(1) Written procedures for fulfilling the requirements of this subpart,

(2) A written record of every product complaint that is related to good manufacturing practice,

(i) The person who performs the requirements of this subpart must document, at the time of performance, that the requirement was performed.

(ii) The written record of the product complaint must include the following:

(A) The name and description of the dietary supplement;

(B) The batch, lot, or control number of the dietary supplement, if available;

(C) The date the complaint was received and the name, address, or telephone number of the complainant, if available;

(D) The nature of the complaint including, if known, how the product was used;

(E) The reply to the complainant, if any; and

(F) Findings of the investigation and followup action taken when an investigation is performed."
21:21:2.0.1.1.11.16.1.1,21,Food and Drugs,I,B,111,"PART 111—CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS",P,Subpart P—Records and Recordkeeping,,§ 111.605 What requirements apply to the records that you make and keep?,FDA,,,,"(a) You must keep written records required by this part for 1 year past the shelf life date, if shelf life dating is used, or 2 years beyond the date of distribution of the last batch of dietary supplements associated with those records.

(b) Records must be kept as original records, as true copies (such as photocopies, microfilm, microfiche, or other accurate reproductions of the original records), or as electronic records.

(c) All electronic records must comply with part 11 of this chapter."
21:21:2.0.1.1.11.16.1.2,21,Food and Drugs,I,B,111,"PART 111—CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS",P,Subpart P—Records and Recordkeeping,,§ 111.610 What records must be made available to FDA?,FDA,,,,"(a) You must have all records required under this part, or copies of such records, readily available during the retention period for inspection and copying by FDA when requested.

(b) If you use reduction techniques, such as microfilming, you must make suitable reader and photocopying equipment readily available to FDA."
21:21:2.0.1.1.11.2.1.1,21,Food and Drugs,I,B,111,"PART 111—CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS",B,Subpart B—Personnel,,§ 111.8 What are the requirements under this subpart B for written procedures?,FDA,,,,You must establish and follow written procedures for fulfilling the requirements of this subpart.
21:21:2.0.1.1.11.2.1.2,21,Food and Drugs,I,B,111,"PART 111—CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS",B,Subpart B—Personnel,,§ 111.10 What requirements apply for preventing microbial contamination from sick or infected personnel and for hygienic practices?,FDA,,,,"(a)  Preventing microbial contamination.  You must take measures to exclude from any operations any person who might be a source of microbial contamination, due to a health condition, where such contamination may occur, of any material, including components, dietary supplements, and contact surfaces used in the manufacture, packaging, labeling, or holding of a dietary supplement. Such measures include the following:

(1) Excluding from working in any operations that may result in contamination any person who, by medical examination, the person's acknowledgement, or supervisory observation, is shown to have, or appears to have, an illness, infection, open lesion, or any other abnormal source of microbial contamination, that could result in microbial contamination of components, dietary supplements, or contact surfaces, until the health condition no longer exists; and

(2) Instructing your employees to notify their supervisor(s) if they have or if there is a reasonable possibility that they have a health condition described in paragraph (a)(1) of this section that could result in microbial contamination of any components, dietary supplements, or any contact surface.

(b)  Hygienic practices.  If you work in an operation during which adulteration of the component, dietary supplement, or contact surface could occur, you must use hygienic practices to the extent necessary to protect against such contamination of components, dietary supplements, or contact surfaces. These hygienic practices include the following:

(1) Wearing outer garments in a manner that protects against the contamination of components, dietary supplements, or any contact surface;

(2) Maintaining adequate personal cleanliness;

(3) Washing hands thoroughly (and sanitizing if necessary to protect against contamination with microorganisms) in an adequate hand-washing facility:

(i) Before starting work; and

(ii) At any time when the hands may have become soiled or contaminated;

(4) Removing all unsecured jewelry and other objects that might fall into components, dietary supplements, equipment, or packaging, and removing hand jewelry that cannot be adequately sanitized during periods in which components or dietary supplements are manipulated by hand. If hand jewelry cannot be removed, it must be covered by material that is maintained in an intact, clean, and sanitary condition and that effectively protects against contamination of components, dietary supplements, or contact surfaces;

(5) Maintaining gloves used in handling components or dietary supplements in an intact, clean, and sanitary condition. The gloves must be of an impermeable material;

(6) Wearing, where appropriate, in an effective manner, hair nets, caps, beard covers, or other effective hair restraints;

(7) Not storing clothing or other personal belongings in areas where components, dietary supplements, or any contact surfaces are exposed or where contact surfaces are washed;

(8) Not eating food, chewing gum, drinking beverages, or using tobacco products in areas where components, dietary supplements, or any contact surfaces are exposed, or where contact surfaces are washed; and

(9) Taking any other precautions necessary to protect against the contamination of components, dietary supplements, or contact surfaces with microorganisms, filth, or any other extraneous materials, including perspiration, hair, cosmetics, tobacco, chemicals, and medicines applied to the skin."
21:21:2.0.1.1.11.2.1.3,21,Food and Drugs,I,B,111,"PART 111—CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS",B,Subpart B—Personnel,,§ 111.12 What personnel qualification requirements apply?,FDA,,,,"(a) You must have qualified employees who manufacture, package, label, or hold dietary supplements.

(b) You must identify who is responsible for your quality control operations. Each person who is identified to perform quality control operations must be qualified to do so and have distinct and separate responsibilities related to performing such operations from those responsibilities that the person otherwise has when not performing such operations.

(c) Each person engaged in manufacturing, packaging, labeling, or holding, or in performing any quality control operations, must have the education, training, or experience to perform the person's assigned functions."
21:21:2.0.1.1.11.2.1.4,21,Food and Drugs,I,B,111,"PART 111—CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS",B,Subpart B—Personnel,,§ 111.13 What supervisor requirements apply?,FDA,,,,"(a) You must assign qualified personnel to supervise the manufacturing, packaging, labeling, or holding of dietary supplements.

(b) Each supervisor whom you use must be qualified by education, training, or experience to supervise."
21:21:2.0.1.1.11.2.1.5,21,Food and Drugs,I,B,111,"PART 111—CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS",B,Subpart B—Personnel,,"§ 111.14 Under this subpart B, what records must you make and keep?",FDA,,,,"(a) You must make and keep records required under this subpart B in accordance with subpart P of this part.

(b) You must make and keep the following records:

(1) Written procedures for fulfilling the requirements of this subpart B; and

(2) Documentation of training, including the date of the training, the type of training, and the person(s) trained."
21:21:2.0.1.1.11.3.1.1,21,Food and Drugs,I,B,111,"PART 111—CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS",C,Subpart C—Physical Plant and Grounds,,§ 111.15 What sanitation requirements apply to your physical plant and grounds?,FDA,,,,"(a)  Grounds.  You must keep the grounds of your physical plant in a condition that protects against the contamination of components, dietary supplements, or contact surfaces. The methods for adequate ground maintenance include:

(1) Properly storing equipment, removing litter and waste, and cutting weeds or grass within the immediate vicinity of the physical plant so that it does not attract pests, harbor pests, or provide pests a place for breeding;

(2) Maintaining roads, yards, and parking lots so that they do not constitute a source of contamination in areas where components, dietary supplements, or contact surfaces are exposed;

(3) Adequately draining areas that may contribute to the contamination of components, dietary supplements, or contact surfaces by seepage, filth or any other extraneous materials, or by providing a breeding place for pests;

(4) Adequately operating systems for waste treatment and disposal so that they do not constitute a source of contamination in areas where components, dietary supplements, or contact surfaces are exposed; and

(5) If your plant grounds are bordered by grounds not under your control, and if those other grounds are not maintained in the manner described in this section, you must exercise care in the plant by inspection, extermination, or other means to exclude pests, dirt, and filth or any other extraneous materials that may be a source of contamination.

(b)  Physical plant facilities.  (1) You must maintain your physical plant in a clean and sanitary condition; and

(2) You must maintain your physical plant in repair sufficient to prevent components, dietary supplements, or contact surfaces from becoming contaminated.

(c)  Cleaning compounds, sanitizing agents, pesticides, and other toxic materials.  (1) You must use cleaning compounds and sanitizing agents that are free from microorganisms of public health significance and that are safe and adequate under the conditions of use.

(2) You must not use or hold toxic materials in a physical plant in which components, dietary supplements, or contact surfaces are manufactured or exposed, unless those materials are necessary as follows:

(i) To maintain clean and sanitary conditions;

(ii) For use in laboratory testing procedures;

(iii) For maintaining or operating the physical plant or equipment; or

(iv) For use in the plant's operations.

(3) You must identify and hold cleaning compounds, sanitizing agents, pesticides, pesticide chemicals, and other toxic materials in a manner that protects against contamination of components, dietary supplements, or contact surfaces.

(d)  Pest control.  (1) You must not allow animals or pests in any area of your physical plant. Guard or guide dogs are allowed in some areas of your physical plant if the presence of the dogs will not result in contamination of components, dietary supplements, or contact surfaces;

(2) You must take effective measures to exclude pests from the physical plant and to protect against contamination of components, dietary supplements, and contact surfaces on the premises by pests; and

(3) You must not use insecticides, fumigants, fungicides, or rodenticides, unless you take precautions to protect against the contamination of components, dietary supplements, or contact surfaces.

(e)  Water supply.  (1) You must provide water that is safe and sanitary, at suitable temperatures, and under pressure as needed, for all uses where water does not become a component of the dietary supplement.

(2) Water that is used in a manner such that the water may become a component of the dietary supplement, e.g., when such water contacts components, dietary supplements, or any contact surface, must, at a minimum, comply with applicable Federal, State, and local requirements and not contaminate the dietary supplement.

(f)  Plumbing.  The plumbing in your physical plant must be of an adequate size and design and be adequately installed and maintained to:

(1) Carry sufficient amounts of water to required locations throughout the physical plant;

(2) Properly convey sewage and liquid disposable waste from your physical plant;

(3) Avoid being a source of contamination to components, dietary supplements, water supplies, or any contact surface, or creating an unsanitary condition;

(4) Provide adequate floor drainage in all areas where floors are subject to flooding-type cleaning or where normal operations release or discharge water or other liquid waste on the floor; and

(5) Not allow backflow from, or cross connection between, piping systems that discharge waste water or sewage and piping systems that carry water used for manufacturing dietary supplements, for cleaning contact surfaces, or for use in bathrooms or hand-washing facilities.

(g)  Sewage disposal.  You must dispose of sewage into an adequate sewage system or through other adequate means.

(h)  Bathrooms.  You must provide your employees with adequate, readily accessible bathrooms. The bathrooms must be kept clean and must not be a potential source of contamination to components, dietary supplements, or contact surfaces.

(i)  Hand-washing facilities.  You must provide hand-washing facilities that are designed to ensure that an employee's hands are not a source of contamination of components, dietary supplements, or any contact surface, by providing facilities that are adequate, convenient, and furnish running water at a suitable temperature.

(j)  Trash disposal.  You must convey, store, and dispose of trash to:

(1) Minimize the development of odors;

(2) Minimize the potential for the trash to attract, harbor, or become a breeding place for pests;

(3) Protect against contamination of components, dietary supplements, any contact surface, water supplies, and grounds surrounding your physical plant; and

(4) Control hazardous waste to prevent contamination of components, dietary supplements, and contact surfaces.

(k)  Sanitation supervisors.  You must assign one or more employees to supervise overall sanitation. Each of these supervisors must be qualified by education, training, or experience to develop and supervise sanitation procedures."
21:21:2.0.1.1.11.3.1.2,21,Food and Drugs,I,B,111,"PART 111—CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS",C,Subpart C—Physical Plant and Grounds,,§ 111.16 What are the requirements under this subpart C for written procedures?,FDA,,,,You must establish and follow written procedures for cleaning the physical plant and for pest control.
21:21:2.0.1.1.11.3.1.3,21,Food and Drugs,I,B,111,"PART 111—CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS",C,Subpart C—Physical Plant and Grounds,,§ 111.20 What design and construction requirements apply to your physical plant?,FDA,,,,"Any physical plant you use in the manufacture, packaging, labeling, or holding of dietary supplements must:

(a) Be suitable in size, construction, and design to facilitate maintenance, cleaning, and sanitizing operations;

(b) Have adequate space for the orderly placement of equipment and holding of materials as is necessary for maintenance, cleaning, and sanitizing operations and to prevent contamination and mixups of components and dietary supplements during manufacturing, packaging, labeling, or holding;

(c) Permit the use of proper precautions to reduce the potential for mixups or contamination of components, dietary supplements, or contact surfaces, with microorganisms, chemicals, filth, or other extraneous material. Your physical plant must have, and you must use, separate or defined areas of adequate size or other control systems, such as computerized inventory controls or automated systems of separation, to prevent contamination and mixups of components and dietary supplements during the following operations:

(1) Receiving, identifying, holding, and withholding from use, components, dietary supplements, packaging, and labels that will be used in or during the manufacturing, packaging, labeling, or holding of dietary supplements;

(2) Separating, as necessary, components, dietary supplements, packaging, and labels that are to be used in manufacturing from components, dietary supplements, packaging, or labels that are awaiting material review and disposition decision, reprocessing, or are awaiting disposal after rejection;

(3) Separating the manufacturing, packaging, labeling, and holding of different product types including different types of dietary supplements and other foods, cosmetics, and pharmaceutical products;

(4) Performing laboratory analyses and holding laboratory supplies and samples;

(5) Cleaning and sanitizing contact surfaces;

(6) Packaging and label operations; and

(7) Holding components or dietary supplements.

(d) Be designed and constructed in a manner that prevents contamination of components, dietary supplements, or contact surfaces.

(1) The design and construction must include:

(i) Floors, walls, and ceilings that can be adequately cleaned and kept clean and in good repair;

(ii) Fixtures, ducts, and pipes that do not contaminate components, dietary supplements, or contact surfaces by dripping or other leakage, or condensate;

(iii) Adequate ventilation or environmental control equipment such as airflow systems, including filters, fans, and other air-blowing equipment, that minimize odors and vapors (including steam and noxious fumes) in areas where they may contaminate components, dietary supplements, or contact surfaces;

(iv) Equipment that controls temperature and humidity, when such equipment is necessary to ensure the quality of the dietary supplement; and

(v) Aisles or working spaces between equipment and walls that are adequately unobstructed and of adequate width to permit all persons to perform their duties and to protect against contamination of components, dietary supplements, or contact surfaces with clothing or personal contact.

(2) When fans and other air-blowing equipment are used, such fans and equipment must be located and operated in a manner that minimizes the potential for microorganisms and particulate matter to contaminate components, dietary supplements, or contact surfaces;

(e) Provide adequate light in:

(1) All areas where components or dietary supplements are examined, processed, or held;

(2) All areas where contact surfaces are cleaned; and

(3) Hand-washing areas, dressing and locker rooms, and bathrooms.

(f) Use safety-type light bulbs, fixtures, skylights, or other glass or glass-like materials when the light bulbs, fixtures, skylights or other glass or glass-like materials are suspended over exposed components or dietary supplements in any step of preparation, unless your physical plant is otherwise constructed in a manner that will protect against contamination of components or dietary supplements in case of breakage of glass or glass-like materials.

(g) Provide effective protection against contamination of components and dietary supplements in bulk fermentation vessels, by, for example:

(1) Use of protective coverings;

(2) Placement in areas where you can eliminate harborages for pests over and around the vessels;

(3) Placement in areas where you can check regularly for pests, pest infestation, filth or any other extraneous materials; and

(4) Use of skimming equipment.

(h) Use adequate screening or other protection against pests, where necessary."
21:21:2.0.1.1.11.3.1.4,21,Food and Drugs,I,B,111,"PART 111—CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS",C,Subpart C—Physical Plant and Grounds,,"§ 111.23 Under this subpart C, what records must you make and keep?",FDA,,,,"(a) You must make and keep records required under this subpart C in accordance with subpart P of this part.

(b) You must make and keep records of the written procedures for cleaning the physical plant and for pest control.

(c) You must make and keep records that show that water, when used in a manner such that the water may become a component of the dietary supplement, meets the requirements of § 111.15(e)(2)."
21:21:2.0.1.1.11.4.1.1,21,Food and Drugs,I,B,111,"PART 111—CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS",D,Subpart D—Equipment and Utensils,,§ 111.25 What are the requirements under this subpart D for written procedures?,FDA,,,,"You must establish and follow written procedures for fulfilling the requirements of this subpart D, including written procedures for:

(a) Calibrating instruments and controls that you use in manufacturing or testing a component or dietary supplement;

(b) Calibrating, inspecting, and checking automated, mechanical, and electronic equipment; and

(c) Maintaining, cleaning, and sanitizing, as necessary, all equipment, utensils, and any other contact surfaces that are used to manufacture, package, label, or hold components or dietary supplements."
21:21:2.0.1.1.11.4.1.2,21,Food and Drugs,I,B,111,"PART 111—CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS",D,Subpart D—Equipment and Utensils,,§ 111.27 What requirements apply to the equipment and utensils that you use?,FDA,,,"[72 FR 34942, June 25, 2007, as amended at 73 FR 13124, Mar. 12, 2008]","(a) You must use equipment and utensils that are of appropriate design, construction, and workmanship to enable them to be suitable for their intended use and to be adequately cleaned and properly maintained.

(1) Equipment and utensils include the following:

(i) Equipment used to hold or convey;

(ii) Equipment used to measure;

(iii) Equipment using compressed air or gas;

(iv) Equipment used to carry out processes in closed pipes and vessels; and

(v) Equipment used in automated, mechanical, or electronic systems.

(2) You must use equipment and utensils of appropriate design and construction so that use will not result in the contamination of components or dietary supplements with:

(i) Lubricants;

(ii) Fuel;

(iii) Coolants;

(iv) Metal or glass fragments;

(v) Filth or any other extraneous material;

(vi) Contaminated water; or

(vii) Any other contaminants.

(3) All equipment and utensils you use must be:

(i) Installed and maintained to facilitate cleaning the equipment, utensils, and all adjacent spaces;

(ii) Corrosion-resistant if the equipment or utensils contact components or dietary supplements;

(iii) Made of nontoxic materials;

(iv) Designed and constructed to withstand the environment in which they are used, the action of components or dietary supplements, and, if applicable, cleaning compounds and sanitizing agents; and

(v) Maintained to protect components and dietary supplements from being contaminated by any source.

(4) Equipment and utensils you use must have seams that are smoothly bonded or maintained to minimize accumulation of dirt, filth, organic material, particles of components or dietary supplements, or any other extraneous materials or contaminants.

(5) Each freezer, refrigerator, and other cold storage compartment you use to hold components or dietary supplements:

(i) Must be fitted with an indicating thermometer, temperature-measuring device, or temperature-recording device that indicates and records, or allows for recording by hand, the temperature accurately within the compartment; and

(ii) Must have an automated device for regulating temperature or an automated alarm system to indicate a significant temperature change in a manual operation.

(6) Instruments or controls used in the manufacturing, packaging, labeling, or holding of a dietary supplement, and instruments or controls that you use to measure, regulate, or record temperatures, hydrogen-ion concentration (pH), water activity, or other conditions, to control or prevent the growth of microorganisms or other contamination must be:

(i) Accurate and precise;

(ii) Adequately maintained; and

(iii) Adequate in number for their designated uses.

(7) Compressed air or other gases you introduce mechanically into or onto a component, dietary supplement, or contact surface or that you use to clean any contact surface must be treated in such a way that the component, dietary supplement, or contact surface is not contaminated.

(b) You must calibrate instruments and controls you use in manufacturing or testing a component or dietary supplement. You must calibrate:

(1) Before first use; and

(2) At the frequency specified in writing by the manufacturer of the instrument and control; or

(3) At routine intervals or as otherwise necessary to ensure the accuracy and precision of the instrument and control.

(c) You must repair or replace instruments or controls that cannot be adjusted to agree with the reference standard.

(d) You must maintain, clean, and sanitize, as necessary, all equipment, utensils, and any other contact surfaces used to manufacture, package, label, or hold components or dietary supplements.

(1) Equipment and utensils must be taken apart as necessary for thorough maintenance, cleaning, and sanitizing.

(2) You must ensure that all contact surfaces, used for manufacturing or holding low-moisture components or dietary supplements, are in a dry and sanitary condition when in use. When the surfaces are wet-cleaned, they must be sanitized, when necessary, and thoroughly dried before subsequent use.

(3) If you use wet processing during manufacturing, you must clean and sanitize all contact surfaces, as necessary, to protect against the introduction of microorganisms into components or dietary supplements. When cleaning and sanitizing is necessary, you must clean and sanitize all contact surfaces before use and after any interruption during which the contact surface may have become contaminated. If you use contact surfaces in a continuous production operation or in consecutive operations involving different batches of the same dietary supplement, you must adequately clean and sanitize the contact surfaces, as necessary.

(4) You must clean surfaces that do not come into direct contact with components or dietary supplements as frequently as necessary to protect against contaminating components or dietary supplements.

(5) Single-service articles (such as utensils intended for one-time use, paper cups, and paper towels) must be:

(i) Stored in appropriate containers; and

(ii) Handled, dispensed, used, and disposed of in a manner that protects against contamination of components, dietary supplements, or any contact surface.

(6) Cleaning compounds and sanitizing agents must be adequate for their intended use and safe under their conditions of use;

(7) You must store cleaned and sanitized portable equipment and utensils that have contact surfaces in a location and manner that protects them from contamination."
21:21:2.0.1.1.11.4.1.3,21,Food and Drugs,I,B,111,"PART 111—CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS",D,Subpart D—Equipment and Utensils,,"§ 111.30 What requirements apply to automated, mechanical, or electronic equipment?",FDA,,,,"For any automated, mechanical, or electronic equipment that you use to manufacture, package, label, or hold a dietary supplement, you must:

(a) Design or select equipment to ensure that dietary supplement specifications are consistently met;

(b) Determine the suitability of the equipment by ensuring that your equipment is capable of operating satisfactorily within the operating limits required by the process;

(c) Routinely calibrate, inspect, or check the equipment to ensure proper performance. Your quality control personnel must periodically review these calibrations, inspections, or checks;

(d) Establish and use appropriate controls for automated, mechanical, and electronic equipment (including software for a computer controlled process) to ensure that any changes to the manufacturing, packaging, labeling, holding, or other operations are approved by quality control personnel and instituted only by authorized personnel; and

(e) Establish and use appropriate controls to ensure that the equipment functions in accordance with its intended use. These controls must be approved by quality control personnel."
21:21:2.0.1.1.11.4.1.4,21,Food and Drugs,I,B,111,"PART 111—CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS",D,Subpart D—Equipment and Utensils,,"§ 111.35 Under this subpart D, what records must you make and keep?",FDA,,,,"(a) You must make and keep records required under this subpart D in accordance with subpart P of this part.

(b) You must make and keep the following records:

(1) Written procedures for fulfilling the requirements of this subpart, including written procedures for:

(i) Calibrating instruments and controls that you use in manufacturing or testing a component or dietary supplement;

(ii) Calibrating, inspecting, and checking automated, mechanical, and electronic equipment; and

(iii) Maintaining, cleaning, and sanitizing, as necessary, all equipment, utensils, and any other contact surfaces that are used to manufacture, package, label, or hold components or dietary supplements;

(2) Documentation, in individual equipment logs, of the date of the use, maintenance, cleaning, and sanitizing of equipment, unless such documentation is kept with the batch record;

(3) Documentation of any calibration, each time the calibration is performed, for instruments and controls that you use in manufacturing or testing a component or dietary supplement. In your documentation, you must:

(i) Identify the instrument or control calibrated;

(ii) Provide the date of calibration;

(iii) Identify the reference standard used including the certification of accuracy of the known reference standard and a history of recertification of accuracy;

(iv) Identify the calibration method used, including appropriate limits for accuracy and precision of instruments and controls when calibrating;

(v) Provide the calibration reading or readings found;

(vi) Identify the recalibration method used, and reading or readings found, if accuracy or precision or both accuracy and precision limits for instruments and controls were not met; and

(vii) Include the initials of the person who performed the calibration and any recalibration.

(4) Written records of calibrations, inspections, and checks of automated, mechanical, and electronic equipment;

(5) Backup file(s) of current software programs (and of outdated software that is necessary to retrieve records that you are required to keep in accordance with subpart P of this part, when current software is not able to retrieve such records) and of data entered into computer systems that you use to manufacture, package, label, or hold dietary supplements.

(i) Your backup file (e.g., a hard copy of data you have entered, diskettes, tapes, microfilm, or compact disks) must be an exact and complete record of the data you entered.

(ii) You must keep your backup software programs and data secure from alterations, inadvertent erasures, or loss; and

(6) Documentation of the controls that you use to ensure that equipment functions in accordance with its intended use."
21:21:2.0.1.1.11.5.1.1,21,Food and Drugs,I,B,111,"PART 111—CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS",E,Subpart E—Requirement to Establish a Production and Process Control System,,§ 111.55 What are the requirements to implement a production and process control system?,FDA,,,,"You must implement a system of production and process controls that covers all stages of manufacturing, packaging, labeling, and holding of the dietary supplement to ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record."
21:21:2.0.1.1.11.5.1.10,21,Food and Drugs,I,B,111,"PART 111—CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS",E,Subpart E—Requirement to Establish a Production and Process Control System,,§ 111.87 Who conducts a material review and makes a disposition decision?,FDA,,,,Quality control personnel must conduct all required material reviews and make all required disposition decisions.
21:21:2.0.1.1.11.5.1.11,21,Food and Drugs,I,B,111,"PART 111—CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS",E,Subpart E—Requirement to Establish a Production and Process Control System,,"§ 111.90 What requirements apply to treatments, in-process adjustments, and reprocessing when there is a deviation or unanticipated occurrence or when a specification established in accordance with § 111.70 is not met?",FDA,,,,"(a) You must not reprocess a rejected dietary supplement or treat or provide an in-process adjustment to a component, packaging, or label to make it suitable for use in the manufacture of a dietary supplement unless:

(1) Quality control personnel conduct a material review and make a disposition decision to approve the reprocessing, treatment, or in-process adjustment; and

(2) The reprocessing, treatment, or in-process adjustment is permitted by § 111.77;

(b) You must not reprocess any dietary supplement or treat or provide an in-process adjustment to a component to make it suitable for use in the manufacture of a dietary supplement, unless:

(1) Quality control personnel conduct a material review and make a disposition decision that is based on a scientifically valid reason and approves the reprocessing, treatment, or in-process adjustment; and

(2) The reprocessing, treatment or in-process adjustment is permitted by § 111.77;

(c) Any batch of dietary supplement that is reprocessed, that contains components that you have treated, or to which you have made in-process adjustments to make them suitable for use in the manufacture of the dietary supplement must be approved by quality control personnel and comply with § 111.123(b) before releasing for distribution."
21:21:2.0.1.1.11.5.1.12,21,Food and Drugs,I,B,111,"PART 111—CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS",E,Subpart E—Requirement to Establish a Production and Process Control System,,"§ 111.95 Under this subpart E, what records must you make and keep?",FDA,,,"[72 FR 34942, June 25, 2007, as amended at 72 FR 34968, June 25, 2007]","(a) You must make and keep records required under this subpart E in accordance with subpart P of this part.

(b) Under this subpart E, you must make and keep the following records:

(1) The specifications established;

(2) Documentation of your qualification of a supplier for the purpose of relying on the supplier's certificate of analysis;

(3) Documentation for why meeting in-process specifications, in combination with meeting component specifications, helps ensure that the dietary supplement meets the specifications for identity, purity, strength, and composition; and for limits on those types of contamination that may adulterate or may lead to adulteration of the finished batch of the dietary supplement; and

(4) Documentation for why the results of appropriate tests or examinations for the product specifications selected under § 111.75(c)(1) ensure that the dietary supplement meets all product specifications;

(5) Documentation for why any component and in-process testing, examination, or monitoring, and any other information, will ensure that a product specification that is exempted under § 111.75(d) is met without verification through periodic testing of the finished batch, including documentation that the selected specifications tested or examined under § 111.75 (c)(1) are not able to verify that the production and process control system is producing a dietary supplement that meets the exempted product specification and there is no scientifically valid method for testing or examining such exempted product specification at the finished batch stage.

(6) Documentation of FDA's response to a petition submitted under § 111.75(a)(1)(ii) providing for an exemption from the provisions of § 111.75(a)(1)(i)."
21:21:2.0.1.1.11.5.1.2,21,Food and Drugs,I,B,111,"PART 111—CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS",E,Subpart E—Requirement to Establish a Production and Process Control System,,§ 111.60 What are the design requirements for the production and process control system?,FDA,,,,"(a) Your production and in-process control system must be designed to ensure that the dietary supplement is manufactured, packaged, labeled, and held in a manner that will ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record; and

(b) The production and in-process control system must include all requirements of subparts E through L of this part and must be reviewed and approved by quality control personnel."
21:21:2.0.1.1.11.5.1.3,21,Food and Drugs,I,B,111,"PART 111—CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS",E,Subpart E—Requirement to Establish a Production and Process Control System,,§ 111.65 What are the requirements for quality control operations?,FDA,,,,"You must implement quality control operations in your manufacturing, packaging, labeling, and holding operations for producing the dietary supplement to ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record."
21:21:2.0.1.1.11.5.1.4,21,Food and Drugs,I,B,111,"PART 111—CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS",E,Subpart E—Requirement to Establish a Production and Process Control System,,§ 111.70 What specifications must you establish?,FDA,,,,"(a) You must establish a specification for any point, step, or stage in the manufacturing process where control is necessary to ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record.

(b) For each component that you use in the manufacture of a dietary supplement, you must establish component specifications as follows:

(1) You must establish an identity specification;

(2) You must establish component specifications that are necessary to ensure that specifications for the purity, strength and composition of dietary supplements manufactured using the components are met; and

(3) You must establish limits on those types of contamination that may adulterate or may lead to adulteration of the finished batch of the dietary supplement to ensure the quality of the dietary supplement.

(c) For the in-process production:

(1) You must establish in-process specifications for any point, step, or stage in the master manufacturing record where control is necessary to help ensure that specifications are met for the identity, purity, strength, and composition of the dietary supplements and, as necessary, for limits on those types of contamination that may adulterate or may lead to adulteration of the finished batch of the dietary supplement;

(2) You must provide adequate documentation of your basis for why meeting the in-process specifications, in combination with meeting component specifications, will help ensure that the specifications are met for the identity, purity, strength, and composition of the dietary supplements and for limits on those types of contamination that may adulterate or may lead to adulteration of the finished batch of the dietary supplement; and

(3) Quality control personnel must review and approve the documentation that you provide under paragraph (c)(2) of this section.

(d) You must establish specifications for dietary supplement labels (label specifications) and for packaging that may come in contact with dietary supplements (packaging specifications). Packaging that may come into contact with dietary supplements must be safe and suitable for its intended use and must not be reactive or absorptive or otherwise affect the safety or quality of the dietary supplement.

(e) For each dietary supplement that you manufacture you must establish product specifications for the identity, purity, strength, and composition of the finished batch of the dietary supplement, and for limits on those types of contamination that may adulterate, or that may lead to adulteration of, the finished batch of the dietary supplement to ensure the quality of the dietary supplement.

(f) If you receive a product from a supplier for packaging or labeling as a dietary supplement (and for distribution rather than for return to the supplier), you must establish specifications to provide sufficient assurance that the product you receive is adequately identified and is consistent with your purchase order.

(g) You must establish specifications for the packaging and labeling of the finished packaged and labeled dietary supplements, including specifications that ensure that you used the specified packaging and that you applied the specified label."
21:21:2.0.1.1.11.5.1.5,21,Food and Drugs,I,B,111,"PART 111—CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS",E,Subpart E—Requirement to Establish a Production and Process Control System,,§ 111.73 What is your responsibility for determining whether established specifications are met?,FDA,,,,You must determine whether the specifications you establish under § 111.70 are met.
21:21:2.0.1.1.11.5.1.6,21,Food and Drugs,I,B,111,"PART 111—CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS",E,Subpart E—Requirement to Establish a Production and Process Control System,,§ 111.75 What must you do to determine whether specifications are met?,FDA,,,"[72 FR 34942, June 25, 2007, as amended at 72 FR 34968, June 25, 2007; 73 FR 27727, May 14, 2008]","(a) Before you use a component, you must:

(1)(i) Conduct at least one appropriate test or examination to verify the identity of any component that is a dietary ingredient, unless you petition the agency under paragraph (a)(1)(ii) of this section and the agency exempts you from such testing;

(ii) You may submit a petition, under 21 CFR 10.30, to request an exemption from the testing requirements in paragraph (a)(1)(i) of this section. The petition must set forth the scientific rationale, and must be accompanied by the supporting data and information, for proposed alternative testing that will demonstrate that there is no material diminution of assurance, compared to the assurance provided by 100 percent identity testing, of the identity of the dietary ingredient before use when the dietary ingredient is obtained from one or more suppliers identified in the petition. If FDA grants the petition, you must conduct the tests and examinations for the dietary ingredient, otherwise required under § 111.75(a)(1)(i), under the terms specified by FDA when the petition is granted; and

(2) Confirm the identity of other components and determine whether other applicable component specifications established in accordance with § 111.70(b) are met. To do so, you must either:

(i) Conduct appropriate tests or examinations; or

(ii) Rely on a certificate of analysis from the supplier of the component that you receive, provided that:

(A) You first qualify the supplier by establishing the reliability of the supplier's certificate of analysis through confirmation of the results of the supplier's tests or examinations;

(B) The certificate of analysis includes a description of the test or examination method(s) used, limits of the test or examinations, and actual results of the tests or examinations;

(C) You maintain documentation of how you qualified the supplier;

(D) You periodically re-confirm the supplier's certificate of analysis; and

(E) Your quality control personnel review and approve the documentation setting forth the basis for qualification (and re-qualification) of any supplier.

(b) You must monitor the in-process points, steps, or stages where control is necessary to ensure the quality of the finished batch of dietary supplement to:

(1) Determine whether the in-process specifications are met; and

(2) Detect any deviation or unanticipated occurrence that may result in a failure to meet specifications.

(c) For a subset of finished dietary supplement batches that you identify through a sound statistical sampling plan (or for every finished batch), you must verify that your finished batch of the dietary supplement meets product specifications for identity, purity, strength, composition, and for limits on those types of contamination that may adulterate or that may lead to adulteration of the finished batch of the dietary supplement. To do so:

(1) You must select one or more established specifications for identity, purity, strength, composition, and the limits on those types of contamination that may adulterate or that may lead to adulteration of the dietary supplement that, if tested or examined on the finished batches of the dietary supplement, would verify that the production and process control system is producing a dietary supplement that meets all product specifications (or only those product specifications not otherwise exempted from this provision by quality control personnel under paragraph (d) of this section);

(2) You must conduct appropriate tests or examinations to determine compliance with the specifications selected in paragraph (c)(1) of this section;

(3) You must provide adequate documentation of your basis for determining that compliance with the specification(s) selected under paragraph (c)(1) of this section, through the use of appropriate tests or examinations conducted under paragraph (c)(2) of this section, will ensure that your finished batch of the dietary supplement meets all product specifications for identity, purity, strength, and composition, and the limits on those types of contamination that may adulterate, or that may lead to the adulteration of, the dietary supplement; and

(4) Your quality control personnel must review and approve the documentation that you provide under paragraph (c)(3) of this section.

(d)(1) You may exempt one or more product specifications from verification requirements in paragraph (c)(1) of this section if you determine and document that the specifications you select under paragraph (c)(1) of this section for determination of compliance with specifications are not able to verify that the production and process control system is producing a dietary supplement that meets the exempted product specification and there is no scientifically valid method for testing or examining such exempted product specification at the finished batch stage. In such a case, you must document why, for example, any component and in-process testing, examination, or monitoring, and any other information, will ensure that such exempted product specification is met without verification through periodic testing of the finished batch; and

(2) Your quality control personnel must review and approve the documentation that you provide under paragraph (d)(1) of this section.

(e) Before you package or label a product that you receive for packaging or labeling as a dietary supplement (and for distribution rather than for return to the supplier), you must visually examine the product and have documentation to determine whether the specifications that you established under § 111.70 (f) are met.

(f)(1) Before you use packaging, you must, at a minimum, conduct a visual identification of the containers and closures and review the supplier's invoice, guarantee, or certification to determine whether the packaging specifications are met; and

(2) Before you use labels, you must, at a minimum, conduct a visual examination of the label and review the supplier's invoice, guarantee, or certification to determine whether label specifications are met.

(g) You must, at a minimum, conduct a visual examination of the packaging and labeling of the finished packaged and labeled dietary supplements to determine whether you used the specified packaging and applied the specified label.

(h)(1) You must ensure that the tests and examinations that you use to determine whether the specifications are met are appropriate, scientifically valid methods.

(2) The tests and examinations that you use must include at least one of the following:

(i) Gross organoleptic analysis;

(ii) Macroscopic analysis;

(iii) Microscopic analysis;

(iv) Chemical analysis; or

(v) Other scientifically valid methods.

(i) You must establish corrective action plans for use when an established specification is not met."
21:21:2.0.1.1.11.5.1.7,21,Food and Drugs,I,B,111,"PART 111—CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS",E,Subpart E—Requirement to Establish a Production and Process Control System,,§ 111.77 What must you do if established specifications are not met?,FDA,,,,"(a) For specifications established under § 111.70(a), (b)(2), (b)(3), (c), (d), (e), and (g) that you do not meet, quality control personnel, in accordance with the requirements in subpart F of this part, must reject the component, dietary supplement, package or label unless such personnel approve a treatment, an in-process adjustment, or reprocessing that will ensure the quality of the finished dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record. No finished batch of dietary supplements may be released for distribution unless it complies with § 111.123(b).

(b) For specifications established under § 111.70(b)(1) that you do not meet, quality control personnel must reject the component and the component must not be used in manufacturing the dietary supplement.

(c) For specifications established under § 111.70(f) that you do not meet, quality control personnel must reject the product and the product may not be packaged or labeled for distribution as a dietary supplement."
21:21:2.0.1.1.11.5.1.8,21,Food and Drugs,I,B,111,"PART 111—CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS",E,Subpart E—Requirement to Establish a Production and Process Control System,,§ 111.80 What representative samples must you collect?,FDA,,,,"The representative samples that you must collect include:

(a) Representative samples of each unique lot of components, packaging, and labels that you use to determine whether the components, packaging, and labels meet specifications established in accordance with § 111.70(b) and (d), and as applicable, § 111.70(a) (and, when you receive components, packaging, or labels from a supplier, representative samples of each unique shipment, and of each unique lot within each unique shipment);

(b) Representative samples of in-process materials for each manufactured batch at points, steps, or stages, in the manufacturing process as specified in the master manufacturing record where control is necessary to ensure the identity, purity, strength, and composition of dietary supplements to determine whether the in-process materials meet specifications established in accordance with § 111.70(c), and as applicable, § 111.70(a);

(c) Representative samples of a subset of finished batches of each dietary supplement that you manufacture, which you identify through a sound statistical sampling plan (or otherwise every finished batch), before releasing for distribution to verify that the finished batch of dietary supplement meets product specifications established in accordance with § 111.70(e), and as applicable, § 111.70(a);

(d) Representative samples of each unique shipment, and of each unique lot within each unique shipment, of product that you receive for packaging or labeling as a dietary supplement (and for distribution rather than for return to the supplier) to determine whether the received product meets specifications established in accordance with § 111.70(f), and as applicable, § 111.70(a); and

(e) Representative samples of each lot of packaged and labeled dietary supplements to determine whether the packaging and labeling of the finished packaged and labeled dietary supplements meet specifications established in accordance with § 111.70(g), and as applicable, § 111.70(a)."
21:21:2.0.1.1.11.5.1.9,21,Food and Drugs,I,B,111,"PART 111—CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS",E,Subpart E—Requirement to Establish a Production and Process Control System,,§ 111.83 What are the requirements for reserve samples?,FDA,,,,"(a) You must collect and hold reserve samples of each lot of packaged and labeled dietary supplements that you distribute.

(b) The reserve samples must:

(1) Be held using the same container-closure system in which the packaged and labeled dietary supplement is distributed, or if distributing dietary supplements to be packaged and labeled, using a container-closure system that provides essentially the same characteristics to protect against contamination or deterioration as the one in which it is distributed for packaging and labeling elsewhere;

(2) Be identified with the batch, lot, or control number;

(3) Be retained for 1 year past the shelf life date (if shelf life dating is used), or for 2 years from the date of distribution of the last batch of dietary supplements associated with the reserve sample, for use in appropriate investigations; and

(4) Consist of at least twice the quantity necessary for all tests or examinations to determine whether or not the dietary supplement meets product specifications."
21:21:2.0.1.1.11.6.1.1,21,Food and Drugs,I,B,111,"PART 111—CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS",F,Subpart F—Production and Process Control System: Requirements for Quality Control,,§ 111.103 What are the requirements under this subpart F for written procedures?,FDA,,,,"You must establish and follow written procedures for the responsibilities of the quality control operations, including written procedures for conducting a material review and making a disposition decision, and for approving or rejecting any reprocessing."
21:21:2.0.1.1.11.6.1.10,21,Food and Drugs,I,B,111,"PART 111—CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS",F,Subpart F—Production and Process Control System: Requirements for Quality Control,,§ 111.135 What quality control operations are required for product complaints?,FDA,,,,Quality control operations for product complaints must include reviewing and approving decisions about whether to investigate a product complaint and reviewing and approving the findings and followup action of any investigation performed.
21:21:2.0.1.1.11.6.1.11,21,Food and Drugs,I,B,111,"PART 111—CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS",F,Subpart F—Production and Process Control System: Requirements for Quality Control,,"§ 111.140 Under this subpart F, what records must you make and keep?",FDA,,,,"(a) You must make and keep the records required under this subpart F in accordance with subpart P of this part.

(b) You must make and keep the following records:

(1) Written procedures for the responsibilities of the quality control operations, including written procedures for conducting a material review and making a disposition decision and written procedures for approving or rejecting any reprocessing;

(2) Written documentation, at the time of performance, that quality control personnel performed the review, approval, or rejection requirements by recording the following:

(i) Date that the review, approval, or rejection was performed; and

(ii) Signature of the person performing the review, approval, or rejection; and

(3) Documentation of any material review and disposition decision and followup. Such documentation must be included in the appropriate batch production record and must include:

(i) Identification of the specific deviation or the unanticipated occurrence;

(ii) Description of your investigation into the cause of the deviation from the specification or the unanticipated occurrence;

(iii) Evaluation of whether or not the deviation or unanticipated occurrence has resulted in or could lead to a failure to ensure the quality of the dietary supplement or a failure to package and label the dietary supplement as specified in the master manufacturing record;

(iv) Identification of the action(s) taken to correct, and prevent a recurrence of, the deviation or the unanticipated occurrence;

(v) Explanation of what you did with the component, dietary supplement, packaging, or label;

(vi) A scientifically valid reason for any reprocessing of a dietary supplement that is rejected or any treatment or in-process adjustment of a component that is rejected; and

(vii) The signature of the individual(s) designated to perform the quality control operation, who conducted the material review and made the disposition decision, and of each qualified individual who provides information relevant to that material review and disposition decision."
21:21:2.0.1.1.11.6.1.2,21,Food and Drugs,I,B,111,"PART 111—CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS",F,Subpart F—Production and Process Control System: Requirements for Quality Control,,§ 111.105 What must quality control personnel do?,FDA,,,,"Quality control personnel must ensure that your manufacturing, packaging, labeling, and holding operations ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record. To do so, quality control personnel must perform operations that include:

(a) Approving or rejecting all processes, specifications, written procedures, controls, tests, and examinations, and deviations from or modifications to them, that may affect the identity, purity, strength, or composition of a dietary supplement;

(b) Reviewing and approving the documentation setting forth the basis for qualification of any supplier;

(c) Reviewing and approving the documentation setting forth the basis for why meeting in-process specifications, in combination with meeting component specifications, will help ensure that the identity, purity, strength, and composition of the dietary supplement are met;

(d) Reviewing and approving the documentation setting forth the basis for why the results of appropriate tests or examinations for each product specification selected under § 111.75(c)(1) will ensure that the finished batch of the dietary supplement meets product specifications;

(e) Reviewing and approving the basis and the documentation for why any product specification is exempted from the verification requirements in § 111.75(c)(1), and for why any component and in-process testing, examination, or monitoring, or other methods will ensure that such exempted product specification is met without verification through periodic testing of the finished batch;

(f) Ensuring that required representative samples are collected;

(g) Ensuring that required reserve samples are collected and held;

(h) Determining whether all specifications established under § 111.70(a) are met; and

(i) Performing other operations required under this subpart."
21:21:2.0.1.1.11.6.1.3,21,Food and Drugs,I,B,111,"PART 111—CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS",F,Subpart F—Production and Process Control System: Requirements for Quality Control,,§ 111.110 What quality control operations are required for laboratory operations associated with the production and process control system?,FDA,,,,"Quality control operations for laboratory operations associated with the production and process control system must include:

(a) Reviewing and approving all laboratory control processes associated with the production and process control system;

(b) Ensuring that all tests and examinations required under § 111.75 are conducted; and

(c) Reviewing and approving the results of all tests and examinations required under § 111.75."